Catalog Number

-

Brand Name

THUNDERBEAT 5 mm, 10 cm, Inline Grip

Version/Model Number

TB-0510IC

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

K111202,K111202

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

402136ba-a1a9-4a31-b0c0-c54f10674d84

Public Version Date

August 29, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170308731

Quantity per Package

5

Contains DI Package

04953170308734

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-