AccessGUDID - DEVICE: Fysh Sunwear (00676190870909)

GUDID

Device Identifier (DI) Information

Brand Name: Fysh Sunwear
Version or Model: F-2150 BLK WHT MARB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F2150S3004818C
Company Name: WestGroupe Optical Inc

Primary DI Number: 00676190870909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 204096080 *Terms of Use

Device Description: Sunglasses ( tinted non-prescription spectacles )

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?
39694	Tinted non-prescription spectacles	An optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQY	Sunglasses (Non-Prescription Including Photosensitive)

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 63285be9-648d-40ee-88a6-13b9ea5c30a5
Public Version Date: December 23, 2025
Public Version Number: 1
DI Record Publish Date: December 15, 2025