Catalog Number

CFR2015

Brand Name

N/A

Version/Model Number

CFR2015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 09, 2023

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

3a838b18-1b22-4090-b317-b7d596e772af

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

October 03, 2018

Package DI Number

50885403474390

Quantity per Package

5

Contains DI Package

10885403474392

Package Discontinue Date

April 09, 2023

Package Status

In Commercial Distribution

Package Type

Case