NA - PROCTOSCOPE OBTURATOR Ø 10MM TL 139MM TL 139mm, - Richard Wolf GmbH

Duns Number:315304071

Device Description: PROCTOSCOPE OBTURATOR Ø 10MM TL 139MM TL 139mm, reusable

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More Product Details

Catalog Number

8836.067

Brand Name

NA

Version/Model Number

8836067

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)

-

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

d8e463c0-bad6-45aa-be7e-438986396ad2

Public Version Date

March 29, 2018

Public Version Number

2

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