FDA UDI
In Commercial Distribution
🇺🇸 United States
Eagle Eyes
DI: 00810712013393
·
Model: 12005SETLG
·
Eagle Eyes
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Eagle Eyes
- Primary DI
- 00810712013393
- Version / Model
- 12005SETLG
- Catalog Number
- 12005SETLG
- Company Name
- Eagle Eyes
- Labeler DUNS
- 611195173
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 2
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- b039ba6a-0291-474b-9b66-c78b254e1cbc
Device Description
GLD Freedom Set Offer #1 w/ Binoculars (1) Freedom Flash GLD 55mm or 52mm - Polarized Sunglasses (1) Aviator NL - Night-Lite® Yellow Non-Polarized Glasses (1) Pair of Binoculars and accessories
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- 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 |
| HJF | Magnifier, Hand-Held, Low-Vision | Ophthalmic | 886.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46297 | Tinted non-prescription spectacle lens | An ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription). | No | Active |
| 30045 | Hand-held magnifier | A magnifying ophthalmic lens with a handle intended to enlarge text/images for a visually impaired patient/person. It is also known as a magnifying glass and can be made of solid plastic material or glass within a plastic or metal frame. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810712013393 | GS1 |