FDA Registration
Active
🇺🇸 United States
MR8 Drill System
Reg #: 1045254
·
FEI: 1045254
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- MEDTRONIC XOMED, INC.
- Registration Number
- 1045254
- FEI Number
- 1045254
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6743 SOUTHPOINT DR. NORTH
- City
- Jacksonville
- State
- FL
- ZIP
- 32216
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183515
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 |
|---|---|---|---|---|---|
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2019-05-22 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2019-05-22 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2019-05-22 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-05-22 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
Proprietary Names
MR8 Drill System
Midas Rex MR8 ClearView Tools
Establishment Types
Manufacture Medical Device