PipelineTM Flex Embolization Device with Shield TechnologyTM

GUDID 00763000284107

STENT PED2-325-25 V06 E-IFU

Micro Therapeutics, Inc.

Bare-metal intracranial vascular stent
Primary Device ID00763000284107
NIH Device Record Key0af8f124-973a-4fb6-90e9-e3bb687eabe2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePipelineTM Flex Embolization Device with Shield TechnologyTM
Version Model NumberPED2-325-25
Company DUNS826110710
Company NameMicro Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000284107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUTIntracranial aneurysm flow diverter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-20
Device Publish Date2021-09-11

On-Brand Devices [PipelineTM Flex Embolization Device with Shield TechnologyTM]

00763000284237STENT PED2-375-12 V06 E-IFU
00763000284756STENT PED2-500-35 V06 E-IFU
00763000284749STENT PED2-500-30 V06 E-IFU
00763000284732STENT PED2-500-25 V06 E-IFU
00763000284725STENT PED2-500-20 V06 E-IFU
00763000284718STENT PED2-500-18 V06 E-IFU
00763000284701STENT PED2-500-16 V06 E-IFU
00763000284695STENT PED2-500-14 V06 E-IFU
00763000284688STENT PED2-500-12 V06 E-IFU
00763000284671STENT PED2-500-10 V06 E-IFU
00763000284664STENT PED2-475-35 V06 E-IFU
00763000284657STENT PED2-475-30 V06 E-IFU
00763000284640STENT PED2-475-25 V06 E-IFU
00763000284633STENT PED2-475-20 V06 E-IFU
00763000284626STENT PED2-475-18 V06 E-IFU
00763000284619STENT PED2-475-16 V06 E-IFU
00763000284602STENT PED2-475-14 V06 E-IFU
00763000284596STENT PED2-475-12 V06 E-IFU
00763000284589STENT PED2-475-10 V06 E-IFU
00763000284572STENT PED2-450-35 V06 E-IFU
00763000284565STENT PED2-450-30 V06 E-IFU
00763000284558STENT PED2-450-25 V06 E-IFU
00763000284541STENT PED2-450-20 V06 E-IFU
00763000284534STENT PED2-450-18 V06 E-IFU
00763000284527STENT PED2-450-16 V06 E-IFU
00763000284510STENT PED2-450-14 V06 E-IFU
00763000284503STENT PED2-450-12 V06 E-IFU
00763000284497STENT PED2-450-10 V06 E-IFU
00763000284480STENT PED2-425-35 V06 E-IFU
00763000284473STENT PED2-425-30 V06 E-IFU
00763000284466STENT PED2-425-25 V06 E-IFU
00763000284459STENT PED2-425-20 V06 E-IFU
00763000284442STENT PED2-425-18 V06 E-IFU
00763000284435STENT PED2-425-16 V06 E-IFU
00763000284428STENT PED2-425-14 V06 E-IFU
00763000284411STENT PED2-425-12 V06 E-IFU
00763000284404STENT PED2-425-10 V06 E-IFU
00763000284398STENT PED2-400-35 V06 E-IFU
00763000284381STENT PED2-400-30 V06 E-IFU
00763000284374STENT PED2-400-25 V06 E-IFU
00763000284367STENT PED2-400-20 V06 E-IFU
00763000284350STENT PED2-400-18 V06 E-IFU
00763000284343STENT PED2-400-16 V06 E-IFU
00763000284336STENT PED2-400-14 V06 E-IFU
00763000284329STENT PED2-400-12 V06 E-IFU
00763000284312STENT PED2-400-10 V06 E-IFU
00763000284305STENT PED2-375-35 V06 E-IFU
00763000284282STENT PED2-375-25 V06 E-IFU
00763000284275STENT PED2-375-20 V06 E-IFU
00763000284268STENT PED2-375-18 V06 E-IFU
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