FDA Registration
Active
🇨🇭 Switzerland
Dexter L6 Handle Grip
Reg #: 3033118964
·
FEI: 3033118964
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DISTALMOTION SA
- Registration Number
- 3033118964
- FEI Number
- 3033118964
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Route de la Corniche 3B
- City
- Epalinges Vaud
- Country
- CH
Regulatory Submissions
- 510(k) Number
- DEN230084
Owner / Operator
- Firm Name
- Distalmotion SA
- Operator Number
- 10091399
- Address
- Route de la Corniche 3B
- City
- Epalinges
- State
- Vaud
- Postal Code
- 1066
- Country
- CH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | SDD | Class 2 | General, Plastic Surgery | No | 2024-10-28 |
Proprietary Names
Dexter L6 Handle Grip
Dexter Needle Holder
Dexter Monopolar Scissors
Dexter Sterile Interface
Dexter Bipolar Johann Grasper
Dexter L6 Emergency Release Tool
Dexter Monopolar Hook
Dexter L6 Endoscope Cart
Dexter L6 Accessory tray
Dexter L6 Robot
Dexter L6 Surgical System
Dexter Bipolar Maryland Dissector
Dexter L6 Incision Pointer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device