AccessGUDID - DEVICE: FUSION DESIGN (04055207014042)

GUDID

Device Identifier (DI) Information

Brand Name: FUSION DESIGN
Version or Model: 8096811
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8096.811
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207014042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: ADAPTER PROJECTOR SIDE for connecting a WOLF light cable to OLYMPUS light sources, 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?
37089	Light source adaptor	A small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. 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
No Device Sizes

Device Record Status

Public Device Record Key: 042d0477-c2ac-45c6-b7b7-f7a4fe55b9aa
Public Version Date: March 16, 2022
Public Version Number: 1
DI Record Publish Date: March 08, 2022