Catalog Number

CER-SUB-1111-OT

Brand Name

CER-SUB-1111-OT

Version/Model Number

11 GA X 11CM

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

K131157,K131157,K131157

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

217bf2d3-c36c-48ac-89b3-82c357bbb934

Public Version Date

October 22, 2021

Public Version Number

1

DI Record Publish Date

October 14, 2021

Package DI Number

10850023741322

Quantity per Package

1

Contains DI Package

00850023741325

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack