FDA Registration
Active
🇲🇽 Mexico
D4000 Drive System
Reg #: 3007305485
·
FEI: 3007305485
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Consolidated Medical Equipment Company
- Registration Number
- 3007305485
- FEI Number
- 3007305485
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ave. Alejandro Dumas No. 11321, Complejo Industrial Chihuahua
- City
- Chihuahua
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K130497
Owner / Operator
- Firm Name
- CONMED CORPORATION
- Operator Number
- 1317214
- Address
- 11311 Concept Boulevard, --
- City
- Largo
- State
- FL
- Postal Code
- 33773
- Country
- US
- Correspondent
- Brent Lalomia
US Agent
- Business Name
- ConMed Corporation
- Contact Name
- Kathryn Reddig
- Address
- 11311 Concept Boulevard
- City
- Largo
- State
- FL
- ZIP
- 33773
- Country
- US
- [email protected]
- Phone
- 727 3995562
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2013-05-31 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2013-05-31 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2013-05-31 |
Proprietary Names
D4000 Drive System
D4000A-Drive System with Irrigation
Artho Power Console
Artho Power Console with Irrigation Pump
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)