Olympus - OLYMPUS Winter & Ibe GmbH

Duns Number:316957240

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More Product Details

Catalog Number

WACL21MS

Brand Name

Olympus

Version/Model Number

WACL21MS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 29, 2020

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

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 Details

Product Code

FAS

Product Code Name

Electrode, Electrosurgical, Active, Urological

Device Record Status

Public Device Record Key

ca95cea5-a97e-40f3-bd3c-0d3ae9a085d0

Public Version Date

August 15, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2016

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