Catalog Number

-

Brand Name

THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S

Version/Model Number

TB-0520FCS

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

f867a1af-508a-4183-9875-09ece7a84b34

Public Version Date

June 21, 2022

Public Version Number

6

DI Record Publish Date

June 05, 2018

Package DI Number

14953170383585

Quantity per Package

1

Contains DI Package

04953170383588

Package Discontinue Date

February 21, 2022

Package Status

Not in Commercial Distribution

Package Type

-