FDA Registration
Active
🇺🇸 United States
NPseal
Reg #: 3019112808
·
FEI: 3019112808
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GUARD MEDICAL INC
- Registration Number
- 3019112808
- FEI Number
- 3019112808
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1221 Brickell Ave Ste 900
- City
- Miami
- State
- FL
- ZIP
- 33131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241522
Owner / Operator
- Firm Name
- Guard Medical Inc
- Operator Number
- 10081853
- Address
- 1221 Brickell Avenue, Suite 900
- City
- Miami
- State
- FL
- Postal Code
- 33131
- Country
- US
- Correspondent
- Laurence Lefebvre
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Negative Pressure Wound Therapy Non-Powered Suction Apparatus | OKO | Class 2 | General, Plastic Surgery | No | 2024-10-18 |
Proprietary Names
NPseal
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility