Catalog Number

CCH2020

Brand Name

N/A

Version/Model Number

CCH2020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 23, 2022

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

36d84c21-db97-456e-aa99-f08fe5f3cb16

Public Version Date

January 24, 2022

Public Version Number

4

DI Record Publish Date

October 03, 2018

Package DI Number

50885403474352

Quantity per Package

5

Contains DI Package

10885403474354

Package Discontinue Date

January 23, 2022

Package Status

Not in Commercial Distribution

Package Type

Case