Catalog Number

-

Brand Name

THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip

Version/Model Number

TB-0545FC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 23, 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

K111202,K111202

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

a9807a0f-65b2-4ee5-a3d5-438e9c0281f7

Public Version Date

August 29, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

14953170337540

Quantity per Package

5

Contains DI Package

04953170337543

Package Discontinue Date

June 23, 2022

Package Status

Not in Commercial Distribution

Package Type

-