FDA Registration
Active
🇺🇸 United States
S-16 Universal Prism Set
Reg #: 2518410
·
FEI: 2518410
·
Expires 2025
Products
1
Proprietary Names
32
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 |
|---|---|---|---|---|---|
| Prism, Bar, Ophthalmic | HKW | Class 1 | Ophthalmic | No | 1992-08-26 |
Proprietary Names
S-16 Universal Prism Set
B-16 Horizontal Prism Bar
B-12 Prism Bar
Magnetic Prism
Magnetic Vergence Facility Stick Prism
Yoked Prism Bar Holder Kit
Yoked Prism Bar Holder
S-4 Prism Set
Vergence Facility Prism
Bishop Alignment Prism Set
Combination Horizontal / Vertical Prism Bar
LB-14 & LB-15 Large Prism Bar Set
Stick Prism
S-22 Universal Prism Set
LB-14 Large Vertical Prism Bar
BV-15 Vertical Prism Bar
S-8 Prism Set
Vergence Facility Stick Prism
MS-10 Prism Set
S-22 Prism Set
BV-15 & B-16 Prism Bar Set
Magnetic Vergence Facility Prism
S-16 Magnetic Stick Prism Set
LB-15 Large Horizontal Prism Bar
SS-8 Prism Set
S-22 Magnetic Stick Prism Set
Magnetic Stick
BV-15 & B-16 Prism Bar Case Set
S-16 Prism Set
Magnetic Stick Prism
Universal Prism
Single Prism
Establishment Types
Manufacture Medical Device