Catalog Number

-

Brand Name

Olympus

Version/Model Number

WA98510E

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"

-

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

f4300696-4eb1-4f7b-91b3-d2fcc2899216

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

October 31, 2017

Package DI Number

36939029815058

Quantity per Package

1000

Contains DI Package

26939029815051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton