Catalog Number

WA63738L

Brand Name

Olmypus

Version/Model Number

WA63738L

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

-

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

K912362,K923982,K944200,K944201

Product Code

EWY

Product Code Name

Mediastinoscope, Surgical

Public Device Record Key

0c8ecf50-8714-48e6-9c0a-4559bf59259c

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-