FDA Registration
Active
🇨🇭 Switzerland
SYNTHES (USA) ELECTRIC PEN DRIVE SY
Reg #: 8030965
·
FEI: 3002807305
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SYNTHES GMBH / Synthes Produktions GmbH
- Registration Number
- 8030965
- FEI Number
- 3002807305
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- EIMATTSTRASSE 3
- City
- Oberdorf, Baselland Basel-Landschaft
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K043310
Owner / Operator
- Firm Name
- SYNTHES GMBH / Synthes Produktions GmbH
- Operator Number
- 9071542
- Address
- 1301 Goshen Parkway
- City
- West Chester
- State
- PA
- Postal Code
- 19380
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2008-01-02 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2008-01-02 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2008-01-02 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2008-01-02 |
Proprietary Names
SYNTHES (USA) ELECTRIC PEN DRIVE SY
Establishment Types
Manufacture Medical Device