FDA Registration
Active
🇺🇸 United States
Maramed Orthopedic Systems
Reg #: 1000560772
·
FEI: 1000560772
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BIOSCULPTOR CORPORATION
- Registration Number
- 1000560772
- FEI Number
- 1000560772
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2480 W 82nd St Unit 1
- City
- Hialeah
- State
- FL
- ZIP
- 33016
- Country
- US
Owner / Operator
- Firm Name
- BioSculptor Corporation
- Operator Number
- 10028416
- Address
- 2480 West 82nd Street, #1, Bay 1A
- City
- Hialeah
- State
- FL
- Postal Code
- 33016
- Country
- US
- Correspondent
- Mark J Mazloff
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2015-01-05 |
Proprietary Names
Maramed Orthopedic Systems
Plastic Colles Splint, Plastic Femur Splint, Plastic Forearm Splint, Plastic Tibia Splint
TFB, TFB-PS, UFB
Miami Fracture Brace
CFB, EO, EO-SG, FC, FFB, HFB, HFB-OS, HFB-SG
Maramed
Plastic Tibia/Fibula Splint
Sky Medical Humeral Facture Orthosis Deltoid Extension, HFO-DE
Sky Medical Ulna Fracture Brace, UFO
Sky Medical Humeral Fracture Orthosis, HFO
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device