AccessGUDID - DEVICE: NA (04055207011249)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 883690
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8836.90
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207011249
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: PROCTOSCOPE HANDLE with cold light illumination and removable connecting part, 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?
63885	Rectoscope/proctoscope handle	A manual device intended to be used as a handle to hold a rectoscope or proctoscope during an examination procedure. It also typically provides attachment sites for inflation and illumination devices, and an end observation window. 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
No Device Sizes

Device Record Status

Public Device Record Key: d3fee4dc-cfa5-47a9-85aa-41145c1e9f11
Public Version Date: June 16, 2022
Public Version Number: 5
DI Record Publish Date: September 26, 2016