AccessGUDID - DEVICE: Skullerz (00720476500667)

GUDID

Device Identifier (DI) Information

Brand Name: Skullerz
Version or Model: DELLENGER-AFAS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50066
Company Name: Ergodyne

Primary DI Number: 00720476500667
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108665142 *Terms of Use

Device Description: Skullerz DELLENGER Enhanced Anti-Fog & Scratch-Resistant Safety Glasses feature adjustable temples that shift up or down and lock into place for a custom fit on a variety of face sizes. These safety glasses feature tough anti-scratch and anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The rimless design makes for a lightweight and comfortable fit and maximizes a full field of vision. A contoured nose bridge won’t slip or pinch and the flex-fit temples reduce pressure and provide stay-put all-day comfort.

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: 7066be87-7fcd-48c6-a697-053d6b21d0ee
Public Version Date: July 26, 2023
Public Version Number: 1
DI Record Publish Date: July 18, 2023