FDA UDI
In Commercial Distribution
🇺🇸 United States
Skullerz
DI: 00720476500681
·
Model: DELLENGER-AFAS
·
Ergodyne
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Skullerz
- Primary DI
- 00720476500681
- Version / Model
- DELLENGER-AFAS
- Catalog Number
- 50068
- Company Name
- Ergodyne
- Labeler DUNS
- 108665142
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-18
- Public Version
- 1
- Public Version Date
- 2023-07-26
- Public Version Status
- New
- Public Device Record Key
- dacca191-2190-49b9-9573-e65e9b2099bb
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | 886.5850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00720476500681 | GS1 |