FDA Registration
Active
🇺🇸 United States
Mediflex Cutting Edge Handle with Ratchet
Reg #: 2424366
·
FEI: 2424366
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FLEXBAR MACHINE CORP.
- Registration Number
- 2424366
- FEI Number
- 2424366
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 250 GIBBS RD.
- City
- ISLANDIA
- State
- NY
- ZIP
- 11749
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081503
Owner / Operator
- Firm Name
- FLEXBAR MACHINE CORP., dba Mediflex
- Operator Number
- 2424366
- Address
- 250 GIBBS RD., --
- City
- Islandia
- State
- NY
- Postal Code
- 11749
- Country
- US
- Correspondent
- Keith P Donaldson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-12-14 |
Proprietary Names
Mediflex Cutting Edge Handle with Ratchet
Mediflex Deluxe Laparoscopic Instruments
Mediflex 3.5mm Laparoscopic Instruments
Establishment Types
Repack or Relabel Medical Device