AccessGUDID - DEVICE: NA (04055207043356)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8834075
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8834.075
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207043356
Issuing Agency: GS1
Commercial Distribution End Date: September 26, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: RECTOSCOPE TUBE Ø 19MM WL 211MM WL 211mm, TL 257mm, straight, 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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36635	Rigid optical rectoscope, 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 rectoscopy. Anatomical images are transmitted to the user typically through relayed lens optics. This device is longer than a proctoscope to provide a deeper view and it is typically equipped with illumination in the distal end. It is typically used to examine the structures of the rectum for irregularities. This is a reusable device.	Active	false

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 211 Millimeter
Outer Diameter: 19 Millimeter

Device Record Status

Public Device Record Key: 27ea10f3-7cf0-4ce3-973c-6e189b2bad23
Public Version Date: November 17, 2023
Public Version Number: 5
DI Record Publish Date: September 26, 2016