Olympus - OLYMPUS Winter & Ibe GmbH

Duns Number:316957240

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More Product Details

Catalog Number

-

Brand Name

Olympus

Version/Model Number

WA9T400V

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2019

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

EOB

Product Code Name

Nasopharyngoscope (Flexible Or Rigid)

Device Record Status

Public Device Record Key

0de12ab8-341b-4cc6-a54e-491e5092c0b5

Public Version Date

August 15, 2022

Public Version Number

3

DI Record Publish Date

April 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OLYMPUS WINTER & IBE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 1109