FDA Registration
Active
🇺🇸 United States
10mm Eye Sphere (non-sterile)
Reg #: 2518410
·
FEI: 2518410
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GULDEN OPHTHALMICS
- Registration Number
- 2518410
- FEI Number
- 2518410
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 225 CADWALADER AVE.
- City
- Elkins Park
- State
- PA
- ZIP
- 19027
- Country
- US
Owner / Operator
- Firm Name
- GULDEN OPHTHALMICS INC
- Operator Number
- 2518410
- Address
- 225 CADWALADER AVE., --
- City
- Elkins Park
- State
- PA
- Postal Code
- 19027
- Country
- US
- Correspondent
- SEAN T COCKLEY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2007-11-08 |
Proprietary Names
10mm Eye Sphere (non-sterile)
18mm Eye Sphere (non-sterile)
14mm Eye Sphere (non-sterile)
20mm Eye Sphere (non-sterile)
22mm Eye Sphere (non-sterile)
12mm Eye Sphere (non-sterile)
16mm Eye Sphere (non-sterile)
Establishment Types
Manufacture Medical Device