INTRO 6207-S1 ACCESSORY 7F Medical Device Identification

GUDID 00681490143011

INTRO 6207-S1 ACCESSORY 7F

MEDTRONIC, INC.

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Primary Device ID	00681490143011
NIH Device Record Key	ab3e135a-17a8-4965-b75e-357586caa168
Commercial Distribution Status	In Commercial Distribution
Version Model Number	6207-S1
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
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	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
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(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
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Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490143011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K911236

FDA Product Code

DYB	INTRODUCER, CATHETER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-06-07
Device Publish Date	2017-01-03

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