Catalog Number

-

Brand Name

Olympus

Version/Model Number

WA98952E

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

HGI

Product Code Name

Electrocautery, Gynecologic (And Accessories)

Public Device Record Key

2cc0a585-529e-4402-a6d7-61e5caea315d

Public Version Date

February 07, 2019

Public Version Number

2

DI Record Publish Date

March 26, 2018

Package DI Number

36939029817205

Quantity per Package

10

Contains DI Package

26939029817208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton