Catalog Number

CBR1041

Brand Name

Cervical Biopsy Punch

Version/Model Number

1

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"

-

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

HFB

Product Code Name

Forceps, Biopsy, Gynecological

Public Device Record Key

23adcc2d-e2b6-4c42-ab44-06b7c39580c7

Public Version Date

November 17, 2021

Public Version Number

1

DI Record Publish Date

November 09, 2021

Package DI Number

05060411985346

Quantity per Package

10

Contains DI Package

05060411985339

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch