Catalog Number

-

Brand Name

HOT BIOPSY FORCEPS

Version/Model Number

FD-1U-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"

Yes

For Single-Use

-

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

K062517,K062517

Product Code

KGE

Product Code Name

FORCEPS, BIOPSY, ELECTRIC

Public Device Record Key

ce7d88bc-5ce2-418a-bd5f-f607ba243293

Public Version Date

November 30, 2021

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

14953170035453

Quantity per Package

1

Contains DI Package

04953170035456

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-