FDA UDI
In Commercial Distribution
🇺🇸 United States
Skullerz
DI: 00720476603009
·
Model: MODI-FAB
·
Ergodyne
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Skullerz
- Primary DI
- 00720476603009
- Version / Model
- MODI-FAB
- Catalog Number
- 60300
- 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
- 6af328fc-c881-48b7-9b77-4ff85e550c17
Device Description
The Skullerz MODI Over-the-Glasses (OTG) Anti-Scratch and Enhanced Anti-Fog Safety Goggles feature an oversized, wrap-around lens for a wide field of vision and seamless fit over prescription frames. These protective safety goggles feature tough anti-scratch and anti-fog polycarbonate lenses to provide clear vision and protect eyes from flying dust, debris and liquid splashes in tough work environments. The soft gasket lining forms to the wearer’s face for a comfortable, customized fit while sealing out dust, debris and particles. The vented frame allows for airflow and improved anti-fog performance. The soft, woven elastic strap is adjustable and comfortably secures on heads, hard hats or caps.
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 | 00720476603009 | GS1 |