SolitiareTM

GUDID 00847536020733

STENT SFR2-6-30 V01 US

Micro Therapeutics, Inc.

Thrombectomy suction catheter
Primary Device ID00847536020733
NIH Device Record Key262001db-3b8a-438b-ae59-6d5683134ccf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolitiareTM
Version Model NumberSFR2-6-30
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536020733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCATHETER, THROMBUS RETRIEVER

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


[00847536020733]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-07

On-Brand Devices [SolitiareTM]

00847536020733STENT SFR2-6-30 V01 US
00847536020726STENT SFR2-6-20 V01 US
00847536020719STENT SFR2-4-20 V01 US
00847536020702STENT SFR2-4-15 V01 US
00847536018464SFR2-4-40 SOLITAIRE FR2 4X40MM

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