FDA Registration
Active
🇺🇸 United States
EDGE, EVOTEC, LUMBITEC, OASIS SOFT, PRIMO, SALO, STEALTH, STOCK MINERVA ATTACHMENTS, STOCK STERNAL PAD KIT
Reg #: 1063727
·
FEI: 3001779564
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OPTEC USA, INC.
- Registration Number
- 1063727
- FEI Number
- 3001779564
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 975 PROGRESS CIRCLE
- City
- LAWRENCEVILLE
- State
- GA
- ZIP
- 30043
- Country
- US
Owner / Operator
- Firm Name
- OPTEC USA, INC.
- Operator Number
- 9033352
- Address
- 975 PROGRESS CIRCLE, --
- City
- Lawrenceville
- State
- GA
- Postal Code
- 30043
- Country
- US
- Correspondent
- Daniel - Suarez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2004-02-11 |
Proprietary Names
EDGE, EVOTEC, LUMBITEC, OASIS SOFT, PRIMO, SALO, STEALTH, STOCK MINERVA ATTACHMENTS, STOCK STERNAL PAD KIT
ORTHOSIS LUMBO-SACRAL
Establishment Types
Repack or Relabel Medical Device