NA - RECTOSCOPE BNDL - Richard Wolf GmbH

Duns Number:315304071

Device Description: RECTOSCOPE BNDL

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More Product Details

Catalog Number

8834.20

Brand Name

NA

Version/Model Number

883420

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

b87b8cfb-78d1-4f0e-a767-0380f13bd498

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

July 21, 2017

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