JETi All In One Accessory Kit

GUDID B139WVTUB12

WALK VASCULAR L.L.C.

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Primary Device IDB139WVTUB12
NIH Device Record Key025151e8-12eb-40de-b183-745eee392599
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETi All In One Accessory Kit
Version Model NumberWVTUB1
Company DUNS034774488
Company NameWALK VASCULAR L.L.C.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB139WVTUB11 [Primary]
HIBCCB139WVTUB12 [Package]
Contains: B139WVTUB11
Package: Corrugated Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEZAspiration Thrombectomy Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-08
Device Publish Date2021-02-26

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