Catalog Number

-

Brand Name

Ethicon

Version/Model Number

CB5ST

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

K172097

Product Code

NLM

Product Code Name

Laparoscope, General & Plastic Surgery, Reprocessed

Public Device Record Key

806995b5-693d-48e3-adbe-5861364279d5

Public Version Date

March 01, 2021

Public Version Number

3

DI Record Publish Date

December 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-