Catalog Number

-

Brand Name

Unimax

Version/Model Number

FEC533050

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"

Yes

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

bfa1da32-6329-464a-9ecb-6258c2db9e69

Public Version Date

March 11, 2021

Public Version Number

1

DI Record Publish Date

March 03, 2021

Package DI Number

14714127866236

Quantity per Package

10

Contains DI Package

04714127866239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Paper Box