Catalog Number

-

Brand Name

Cellebrity

Version/Model Number

M00516000

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

BTG

Product Code Name

BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Public Device Record Key

e8f86cba-9354-4a06-ba4a-d62d1fcc410a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

08714729138983

Quantity per Package

10

Contains DI Package

08714729746232

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-