Catalog Number

-

Brand Name

COX for BIO-FEATHER

Version/Model Number

CB12100-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

K142125,K142125

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

b78ebb2e-4402-4a34-98a9-232f71ba0b86

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

March 07, 2018

Package DI Number

18055002903698

Quantity per Package

10

Contains DI Package

08055002903691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-