AccessGUDID - DEVICE: NA (04055207010679)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 858091
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8580.91
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207010679
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: STERILE ADAPTER Plug-eyepiece for endoscope exchange under sterile conditions, lock mechanism

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?
36292	Endoscope camera adaptor	An optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEM	ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)

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: 40 Millimeter

Device Record Status

Public Device Record Key: d5b5d28b-2cc5-4ad5-9613-7f8e5f4a57a6
Public Version Date: February 29, 2024
Public Version Number: 2
DI Record Publish Date: November 01, 2022