Catalog Number

12100H

Brand Name

NA

Version/Model Number

12100H

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

b9cefdd3-1315-4479-b3f4-a42b88e6ce2e

Public Version Date

January 09, 2020

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

03700393300271

Quantity per Package

25

Contains DI Package

03700393300288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box