AccessGUDID - DEVICE: NA (04055207043516)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8836075
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8836.075
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207043516
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: PROCTOSCOPE TUBE Ø 24MM WL 60MM WL 60mm, TL 75mm, slanted, reusable

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Proctoscope, reusable	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. Anatomical images are transmitted to the user by the device by direct or magnified viewing. This device is longer than an anoscope to provide a deeper view and it is typically equipped with illumination in the distal end. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Proctoscope, reusable

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. Anatomical images are transmitted to the user by the device by direct or magnified viewing. This device is longer than an anoscope to provide a deeper view and it is typically equipped with illumination in the distal end. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
GCM	ENDOSCOPE, RIGID

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Millimeter
Outer Diameter: 24 Millimeter

Device Record Status

Public Device Record Key: 5b97f9c3-028e-4adb-beb1-2921da1ed279
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 26, 2016