Velocity Delivery Microcatheter

GUDID 00814548012629

AdvPX400 STR 160MB

PENUMBRA, INC.

Vascular microcatheter Vascular microcatheter
Primary Device ID00814548012629
NIH Device Record Key4cbc6230-d76d-40d0-81c1-bee95ad36d50
Commercial Distribution StatusIn Commercial Distribution
Brand NameVelocity Delivery Microcatheter
Version Model NumberVEL160STR-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
GS100814548012629 [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 [Velocity Delivery Microcatheter]

00814548012650AdvPX400 J 160MB
00814548012643AdvPX400 90Deg 160MB
00814548012636AdvPX400 45Deg 160MB
00814548012629AdvPX400 STR 160MB
00814548012612AdvPX400 J 150MB
00814548012605AdvPX400 90Deg 150MB
00814548012599AdvPX400 45Deg 150MB
00814548012582AdvPX400 STR 150MB

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