AccessGUDID - DEVICE: Skullerz (00720476573333)

GUDID

Device Identifier (DI) Information

Brand Name: Skullerz
Version or Model: BALDR-AF
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 57333
Company Name: Ergodyne

Primary DI Number: 00720476573333
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 108665142 *Terms of Use

Device Description: Skullerz BALDR Anti-Fog Safety Glasses feature a full-frame design and non-slip rubber temples to keep glasses secure, while also resisting sweat. These safety glasses feature tough anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. Available in a variety of lenses to suit a range of tasks and light environments. The durable frames bend and flex without breaking. The integrated accessory receptors at each temple also improve airflow when not in use. For added safety, an elastic retainer strap or foam gasket insert (both sold separately) can be attached to the temples.

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: 1e98b8d8-b4e1-44fb-9eaa-8ac72d48b78c
Public Version Date: April 03, 2026
Public Version Number: 2
DI Record Publish Date: August 28, 2023