Catalog Number

FRA2015

Brand Name

N/A

Version/Model Number

FRA2015

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

-

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

0ac03309-2c8d-4efe-96d6-cee42ad04f0a

Public Version Date

February 18, 2021

Public Version Number

3

DI Record Publish Date

October 03, 2018

Package DI Number

50885403474949

Quantity per Package

10

Contains DI Package

10885403474941

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case