JETi Saline Drive Unit

GUDID B139WV03451

WALK VASCULAR L.L.C.

Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system
Primary Device IDB139WV03451
NIH Device Record Key88f84b31-516a-40fa-9c68-22d9f4fa66b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETi Saline Drive Unit
Version Model NumberWV0345
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 Usefalse
Lot Batchtrue
Serial Numbertrue
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
HIBCCB139WV03450 [Primary]
HIBCCB139WV03451 [Package]
Contains: B139WV03450
Package: Case [1 Units]
In Commercial Distribution

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 Date2019-06-25
Device Publish Date2019-06-17

On-Brand Devices [JETi Saline Drive Unit]

B139WV034011WV0340-1
B139WV03401WV0340
B139WV00081WV0008
B139WV00071WV0007
B139WV034511WV0345-1
B139WV03451WV0345

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