Catalog Number

8278.011

Brand Name

NA

Version/Model Number

8278011

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BWH

Product Code Name

FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Public Device Record Key

b6beff83-410a-459f-9537-3f3b90fe29d9

Public Version Date

April 26, 2021

Public Version Number

3

DI Record Publish Date

September 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-