RED 68

GUDID 00815948024090

Reperfusion Catheter RED 68, 132cm, CE

PENUMBRA, INC.

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Primary Device ID00815948024090
NIH Device Record Key9fb5e0cc-0845-402e-9cbe-612068a8a1a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameRED 68
Version Model NumberRED68-S
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815948024090 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

On-Brand Devices [RED 68]

00815948024120Reperfusion Catheter RED 68 Kit, 132cm, CE
00815948024113Reperfusion Catheter RED 68 Kit, 132cm
00815948024106Reperfusion Catheter RED 68, 132cm
00815948024090Reperfusion Catheter RED 68, 132cm, CE
00815948023901Reperfusion Catheter RED 68 Kit, 132cm, CE
00815948023895Reperfusion Catheter RED 68 Kit, 132cm
00815948023888Reperfusion Catheter RED 68, 132cm, CE
00815948023871Reperfusion Catheter RED 68, 132cm
00815948024137Reperfusion Catheter RED 68 Kit, 132cm

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