Catalog Number

-

Brand Name

Olympus

Version/Model Number

WA98935E

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

1f532f1b-3482-4f9a-bd0f-df72b754cb67

Public Version Date

May 14, 2018

Public Version Number

1

DI Record Publish Date

April 11, 2018

Package DI Number

26939029817123

Quantity per Package

10

Contains DI Package

16939029817126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton