FDA UDI
In Commercial Distribution
🇺🇸 United States
Skullerz
DI: 00720476592006
·
Model: VALI
·
Ergodyne
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Skullerz
- Primary DI
- 00720476592006
- Version / Model
- VALI
- Catalog Number
- 59200
- Company Name
- Ergodyne
- Labeler DUNS
- 108665142
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-29
- Public Version
- 1
- Public Version Date
- 2023-09-06
- Public Version Status
- New
- Public Device Record Key
- df6b3e37-7eb1-44a5-81ea-a92ed86818bb
Device Description
Skullerz VALI Frameless Safety Glasses are the lightest weight safety glasses in the Skullerz Eye Protection line. These safety glasses feature 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.
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 | 00720476592006 | GS1 |