Catalog Number

-

Brand Name

DISPOSABLE BIOPSY FORCEPS

Version/Model Number

FB-212U

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

-

Product Code

PTS

Product Code Name

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Public Device Record Key

0afc02a5-0022-421f-a302-f582b50d8908

Public Version Date

September 05, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170354158

Quantity per Package

5

Contains DI Package

04953170354151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-