Catalog Number

HBF55-11023180

Brand Name

NA

Version/Model Number

HBF55-11023180

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

K160625,K160625,K160625

Product Code

KGE

Product Code Name

Forceps, Biopsy, Electric

Public Device Record Key

0d9a47ca-514f-48fe-b1d6-5fe2e3052833

Public Version Date

May 21, 2021

Public Version Number

4

DI Record Publish Date

July 01, 2016

Package DI Number

26932503548513

Quantity per Package

10

Contains DI Package

16932503548516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case