Catalog Number

83-10-4010

Brand Name

OMNI

Version/Model Number

83-10-4010

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

029afa42-df9d-4386-b9aa-e01cacb3d27a

Public Version Date

September 03, 2020

Public Version Number

1

DI Record Publish Date

August 26, 2020

Package DI Number

00812231032961

Quantity per Package

1

Contains DI Package

00812231032824

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

83-10-4010-RM