IntraStent LD DoubleStrut S15-16

GUDID 00821684014110

Large Diameter Peripheral Stent

Covidien LP

Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal

Primary Device ID	00821684014110
NIH Device Record Key	4d0c49c9-1ae1-4544-82d0-b10480cb1ec2
Commercial Distribution Status	In Commercial Distribution
Brand Name	IntraStent LD DoubleStrut
Version Model Number	S15-16
Catalog Number	S15-16
Company DUNS	968903703
Company Name	Covidien LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com

Device Dimensions

Length	16 Millimeter
Length	16 Millimeter
Length	16 Millimeter
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
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Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
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Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684014110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993904

FDA Product Code

FGE	CATHETER, BILIARY, DIAGNOSTIC

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-10-09

On-Brand Devices [IntraStent LD DoubleStrut]

00821684014158	Large Diameter Peripheral Stent
00821684014141	Large Diameter Peripheral Stent
00821684014134	Large Diameter Peripheral Stent
00821684014127	Large Diameter Peripheral Stent
00821684014110	Large Diameter Peripheral Stent
00821684014042	Large Diameter Biliary Stent
00821684014035	Large Diameter Biliary Stent
00821684014028	Large Diameter Biliary Stent
00821684014011	Large Diameter Biliary Stent
00821684014004	Large Diameter Biliary Stent