FDA Registration
Active
🇺🇸 United States
Midas Rex Legend Drill System
Reg #: 2647346
·
FEI: 2647346
·
Expires 2025
Products
7
Proprietary Names
5
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
- Registration Number
- 2647346
- FEI Number
- 2647346
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- ROAD 909, KM. 0.4., BARRIO MARIANA
- City
- HUMACAO
- State
- PR
- ZIP
- 00792
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170312
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2017-05-30 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2017-05-30 |
| Saw, Pneumatically Powered | KFK | Class 1 | General, Plastic Surgery | No | 2017-05-30 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2017-05-30 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2017-05-30 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2017-05-30 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2017-05-30 |
Proprietary Names
Midas Rex Legend Drill System
IPC - Integrated Power Console Drill System
Midas Rex Legend Surgical Dissecting Tools
Midas Rex Legend Attachments
Clearview Surgical Dissecting Tools
Establishment Types
Manufacture Medical Device