FDA Registration
Active
🇺🇸 United States
MEDONE SURGICAL, INC.
Reg #: 1064371
·
FEI: 3002865793
·
Expires 2026
Products
11
Proprietary Names
10
Establishment Types
4
Classifications
11
Registration Details
- Registration Name
- MEDONE SURGICAL, INC.
- Registration Number
- 1064371
- FEI Number
- 3002865793
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 1999-10-27 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 1999-10-27 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2016-08-04 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2001-02-05 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-04-27 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1999-10-27 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2013-12-06 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2001-02-05 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2001-06-19 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 1999-10-27 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1999-10-27 |
Proprietary Names
Auricle
MedOne
EyeTech
MicroDose
AdvantEdge
SideFlo
PolyTip
FlexTip
GentleJect
AcuDepth
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)