Olympus - LG-adapter, OES Pro light guide to Wolf telescope - OLYMPUS Winter & Ibe GmbH

Duns Number:316957240

Device Description: LG-adapter, OES Pro light guide to Wolf telescope

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More Product Details

Catalog Number

A03203A

Brand Name

Olympus

Version/Model Number

A03203A

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

GCP

Product Code Name

Endoscope, Ac-Powered And Accessories

Device Record Status

Public Device Record Key

c161ae1e-9e46-43b4-ba6a-af0c8cfee33d

Public Version Date

October 08, 2018

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