Olympus - Versapoint Bipolar Electrode Resectoscopic - 2.5 - OLYMPUS Winter & Ibe GmbH

Duns Number:316957240

Device Description: Versapoint Bipolar Electrode Resectoscopic - 2.5 mm Angled Loop Resecting

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More Product Details

Catalog Number

WA47786A

Brand Name

Olympus

Version/Model Number

WA47786A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

HFI

Product Code Name

Coagulator, Culdoscopic (And Accessories)

Device Record Status

Public Device Record Key

adf810d7-fdca-4ef5-ac64-dddc7dd77c87

Public Version Date

September 13, 2022

Public Version Number

2

DI Record Publish Date

July 31, 2020

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