AccessGUDID - DEVICE: Sweet Protection (B910850082CLEARL)

GUDID

Device Identifier (DI) Information

Brand Name: Sweet Protection
Version or Model: 850082CLEARLENS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ACTIVE BRANDS NORTH AMERICA INC

Primary DI Number: B910850082CLEARL
Issuing Agency: ICCBBA
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079818658 *Terms of Use

Device Description: No description.

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?
46297	Tinted non-prescription spectacle lens	An ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).	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: 2f08fbe5-e830-4df7-8abe-42293bc89639
Public Version Date: August 09, 2021
Public Version Number: 2
DI Record Publish Date: June 26, 2020