Catalog Number

190095

Brand Name

Jawz Endomyocardial Biopsy Forcep

Version/Model Number

190095

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

K951447,K951447

Product Code

DWZ

Product Code Name

Device, Biopsy, Endomyocardial

Public Device Record Key

5a1386da-f010-4452-b84b-294b114c3dbe

Public Version Date

September 10, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

20886333206869

Quantity per Package

10

Contains DI Package

00886333206865

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box