NA - PROCTOSCOPE OBTURATOR Ø 10MM TL 159MM TL 159mm, - Richard Wolf GmbH

Duns Number:315304071

Device Description: PROCTOSCOPE OBTURATOR Ø 10MM TL 159MM TL 159mm, reusable

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More Product Details

Catalog Number

8836.057

Brand Name

NA

Version/Model Number

8836057

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 26, 2016

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)

-

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

GCM

Product Code Name

ENDOSCOPE, RIGID

Device Record Status

Public Device Record Key

892fd3e9-d882-436d-a043-1b67e0fe1386

Public Version Date

June 16, 2022

Public Version Number

3

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RICHARD WOLF GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 587
2 A medical device with a moderate to high risk that requires special controls. 1835