FDA Registration
Active
🇺🇸 United States
MicroDose
Reg #: 1064371
·
FEI: 3002865793
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDONE SURGICAL, INC.
- Registration Number
- 1064371
- FEI Number
- 3002865793
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 670 TALLEVAST ROAD
- City
- SARASOTA
- State
- FL
- ZIP
- 34243
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203264
Owner / Operator
- Firm Name
- MEDONE SURGICAL, INC.
- Operator Number
- 9039435
- Address
- 670 TALLEVAST ROAD, --
- City
- Sarasota
- State
- FL
- Postal Code
- 34243
- Country
- US
- Correspondent
- BRUCE - BECKSTEIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-04-27 |
Proprietary Names
MicroDose
Establishment Types
Manufacture Medical Device