PX SLIM Delivery Microcatheter

GUDID 00814548016429

PXSLIM090

PENUMBRA, INC.

Vascular microcatheter Vascular microcatheter
Primary Device ID00814548016429
NIH Device Record Key8a168473-8e25-4ad0-8b03-d193d27bc263
Commercial Distribution StatusIn Commercial Distribution
Brand NamePX SLIM Delivery Microcatheter
Version Model NumberPXSLIM090
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
GS100814548016429 [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 [PX SLIM Delivery Microcatheter]

00814548016450PXSLIM130
00814548016443PXSLIMSTR-B
00814548016436PXSLIMSTR-A
00814548016429PXSLIM090
00814548016412PXSLIM045-B
00814548016405PXSLIM045-A
00814548012575AdvPX400 J 160DualMB
00814548012568AdvPX400 90Deg 160DualMB
00814548012551AdvPX400 45Deg 160DualMB
00814548012537PXSLIM 150Micro, 130Deg
00814548012520PXSLIM 150Micro, 90Deg
00814548012513AdvPX400 45Deg 150DualMB
00814548012506AdvPX400 STR 150DualMB
00814548010465PXSLIM 150Micro, 130Deg
00814548010342PXSLIM 150Micro, 90Deg

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