ACE

GUDID 00814548013978

RC ACE 64, 115cm

PENUMBRA, INC.

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Primary Device ID00814548013978
NIH Device Record Keyafabd877-3b85-458e-b5eb-7a1f1d0d57f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE
Version Model Number5MAXACE064L115
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814548013978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCATHETER, THROMBUS RETRIEVER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-25

On-Brand Devices [ACE]

008145480166035MAXACE068KIT
008145480165355MAXACE068
008145480165285MAXACE068L127
008145480165115MAXACE068L125
008145480165045MAXACE068L120
008145480164985MAXACE068L115
008145480164675MAXACE064KIT
00814548014005RC ACE 64, 127cm
00814548013992RC ACE 64, 125cm
00814548013985RC ACE 64, 120cm
00814548013978RC ACE 64, 115cm
00814548013961RC ACE 64, 132cm
008159480228505MAXACE068KIT
008159480228435MAXACE068

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