Catalog Number

-

Brand Name

THUNDERBEAT Open Fine Jaw Type X

Version/Model Number

TB-0009OFX

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2022

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

4d4f8e62-d96b-4f40-a879-3b6514bb39b6

Public Version Date

August 29, 2022

Public Version Number

4

DI Record Publish Date

July 08, 2020

Package DI Number

14953170394574

Quantity per Package

5

Contains DI Package

04953170394577

Package Discontinue Date

February 21, 2022

Package Status

Not in Commercial Distribution

Package Type

-