PX400 Microcatheter

GUDID 00814548011639

Penumbra Cat 025 90Deg

PENUMBRA, INC.

Vascular microcatheter Vascular microcatheter
Primary Device ID00814548011639
NIH Device Record Keyba255f78-3608-40b4-b916-67f4e55c13de
Commercial Distribution StatusIn Commercial Distribution
Brand NamePX400 Microcatheter
Version Model NumberPX40090-A
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814548011639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2016-07-30

On-Brand Devices [PX400 Microcatheter]

00814548011653Penumbra Cat 025 STR
00814548011646Penumbra Cat 025 J
00814548011639Penumbra Cat 025 90Deg
00814548011622Penumbra Cat 025 45Deg

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