Solitaire 2 SFR2-4-40

GUDID 00847536003323

Revascularization Device

Micro Therapeutics, Inc.

Bare-metal intracranial vascular stent
Primary Device ID00847536003323
NIH Device Record Key827caf81-b2de-4707-9d50-3ad57726c940
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolitaire 2
Version Model NumberSFR2-4-40
Catalog NumberSFR2-4-40
Company DUNS826110710
Company NameMicro Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length50 Millimeter
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536003323 [Primary]

FDA Product Code

NRYCATHETER, THROMBUS RETRIEVER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-12

On-Brand Devices [Solitaire 2]

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

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