Catalog Number

CER-BN-84

Brand Name

CER-BN-84

Version/Model Number

8GA X 4"

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

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

K983187,K983187,K983187

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

379d82c3-19a9-4bd2-9586-b23f59ac490a

Public Version Date

April 19, 2021

Public Version Number

1

DI Record Publish Date

April 11, 2021

Package DI Number

10850023741025

Quantity per Package

1

Contains DI Package

00850023741028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack