Solitaire 2 SFR2-4-15

GUDID 00836462016378

Revascularization Device

Micro Therapeutics, Inc.

Thrombectomy suction catheter
Primary Device ID00836462016378
NIH Device Record Keyedb516bf-4d05-4b8b-b051-14028f7021a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolitaire 2
Version Model NumberSFR2-4-15
Catalog NumberSFR2-4-15
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
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 Millimeter
Device Size Text, specify0
Outer Diameter4 Millimeter
Length26 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
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
GS100836462016378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-16

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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