Olympus - Versapoint II Electrosurgical Generator - OLYMPUS Winter & Ibe GmbH

Duns Number:316957240

Device Description: Versapoint II Electrosurgical Generator non-sterile, reusable

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More Product Details

Catalog Number

WA47790A

Brand Name

Olympus

Version/Model Number

WA47790A

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

-

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

HIH

Product Code Name

Hysteroscope (And Accessories)

Device Record Status

Public Device Record Key

25efda93-e5d6-4283-aa7a-3c44c3251c21

Public Version Date

August 10, 2020

Public Version Number

1

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