Catalog Number

-

Brand Name

OLYMPUS

Version/Model Number

TB-0545FCX

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

K180575,K180575

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

4eae32dc-0a4e-4eb8-968a-ac0641f55bb3

Public Version Date

February 22, 2022

Public Version Number

3

DI Record Publish Date

January 20, 2019

Package DI Number

14953170392167

Quantity per Package

5

Contains DI Package

04953170392160

Package Discontinue Date

February 21, 2022

Package Status

Not in Commercial Distribution

Package Type

-