JET 5MAXJETD

GUDID 00814548019796

5MAXJETD

PENUMBRA, INC.

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter
Primary Device ID00814548019796
NIH Device Record Key2e80de70-38d8-45be-8f90-ccd734838208
Commercial Distribution StatusIn Commercial Distribution
Brand NameJET
Version Model Number5MAXJETD
Catalog Number5MAXJETD
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 Numberfalse
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
GS100814548019796 [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 Date2018-09-24
Device Publish Date2018-08-23

On-Brand Devices [JET]

008145480198025MAXJETDKIT
008145480197965MAXJETD
008145480197415MAXJETDKIT-A
008145480197345MAXJETD-A

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.