Catalog Number

-

Brand Name

Unimax

Version/Model Number

FPS133059

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

6f004213-b46e-48a8-b03c-d72e12c44f24

Public Version Date

August 18, 2021

Public Version Number

1

DI Record Publish Date

August 10, 2021

Package DI Number

24714127866806

Quantity per Package

10

Contains DI Package

14714127866809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton