JETi All In One Accessory Cart - WALK VASCULAR L.L.C.

Duns Number:034774488

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More Product Details

Catalog Number

-

Brand Name

JETi All In One Accessory Cart

Version/Model Number

WVCART

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 08, 2021

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

QEZ

Product Code Name

Aspiration Thrombectomy Catheter

Device Record Status

Public Device Record Key

0a0b5cfd-890e-452d-bc08-7aa1261e49be

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

February 26, 2021

Additional Identifiers

Package DI Number

B139WVCART2

Quantity per Package

1

Contains DI Package

B139WVCART0

Package Discontinue Date

December 08, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"WALK VASCULAR L.L.C." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 39