Catalog Number

-

Brand Name

Ethicon

Version/Model Number

H12LP

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,K172097,K172097

Product Code

NLM

Product Code Name

Laparoscope, General & Plastic Surgery, Reprocessed

Public Device Record Key

94a5c583-8741-45a4-af12-4dcc35e762fb

Public Version Date

March 01, 2021

Public Version Number

4

DI Record Publish Date

December 12, 2019

Package DI Number

10810041069068

Quantity per Package

6

Contains DI Package

00810041069061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box