Catalog Number

CFR2210

Brand Name

N/A

Version/Model Number

CFR2210

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 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

5abd2691-a3ae-477e-8b6d-1c7709b2d9ca

Public Version Date

February 07, 2022

Public Version Number

4

DI Record Publish Date

October 03, 2018

Package DI Number

50885403474413

Quantity per Package

5

Contains DI Package

10885403474415

Package Discontinue Date

February 06, 2022

Package Status

Not in Commercial Distribution

Package Type

Case