FDA Registration
Active
🇺🇸 United States
Screwdriver, NIDO Assembled Screws, Sleeved
Reg #: 3009165919
·
FEI: 3009165919
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Kalitec Direct LLC DBA Kalitec Medical
- Registration Number
- 3009165919
- FEI Number
- 3009165919
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 865 Oviedo Blvd, Suite 1017
- City
- Oviedo
- State
- FL
- ZIP
- 32765
- Country
- US
Owner / Operator
- Firm Name
- Kalitec Medical
- Operator Number
- 10037099
- Address
- 865 Oviedo Blvd, Suite 1017
- City
- Oviedo
- State
- FL
- Postal Code
- 32765
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-01-02 |
Proprietary Names
Screwdriver, NIDO Assembled Screws, Sleeved
NIDO Screwdriver, Assem Screws SNI1
Screwdriver, NIDO Assembled Screws
NIDO Screwdriver, Modular Bone Screws
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility