Solitaire 2

GUDID 00836462016392

SFR2-6-20 SOLITAIRE 2 DEVICE

Micro Therapeutics, Inc.

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

Primary Device ID	00836462016392
NIH Device Record Key	600da9f4-d89d-4910-9f2a-1129863648d2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Solitaire 2
Version Model Number	SFR2-6-20
Company DUNS	826110710
Company Name	Micro Therapeutics, 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	false
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

Device Dimensions

Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Outer Diameter	6 Millimeter
Length	31 Millimeter
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462016392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123378

FDA Product Code

NRY	CATHETER, THROMBUS RETRIEVER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-07-22
Device Publish Date	2015-10-16

On-Brand Devices [Solitaire 2]

00847536003323	Revascularization Device
00836462016408	SFR2-6-30 SOLITAIRE 2 DEVICE
00836462016392	SFR2-6-20 SOLITAIRE 2 DEVICE
00836462016385	SFR2-4-20 SOLITAIRE 2 DEVICE
00836462016378	Revascularization Device