Catalog Number

CCH2015

Brand Name

N/A

Version/Model Number

CCH2015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 08, 2019

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

a2fc1cee-5e12-4db0-9189-eb3500c7bcb6

Public Version Date

September 09, 2019

Public Version Number

4

DI Record Publish Date

October 03, 2018

Package DI Number

50885403474345

Quantity per Package

5

Contains DI Package

10885403474347

Package Discontinue Date

September 08, 2019

Package Status

Not in Commercial Distribution

Package Type

Case