FDA Registration
Active
🇺🇸 United States
Kalitec Direct LLC DBA Kalitec Medical
Reg #: 3009165919
·
FEI: 3009165919
·
Expires 2025
Products
1
Proprietary Names
0
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 |
|---|---|---|---|---|---|
| Impactor | HWA | Class 1 | Orthopedic | No | 2018-06-20 |
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility