FDA Registration
Active
🇨🇦 Canada
Smartforceps System
Reg #: 3021192541
·
FEI: 3021192541
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORBSURGICAL LTD.
- Registration Number
- 3021192541
- FEI Number
- 3021192541
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HRIC 1C60, 3280 Hospital Drive NW
- City
- Calgary Alberta
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K051429
Owner / Operator
- Firm Name
- OrbSurgical Ltd.
- Operator Number
- 10083634
- Address
- HRIC 1C60, 3280 Hospital Drive NW
- City
- Calgary
- State
- Alberta
- Postal Code
- T2N 4Z6
- Country
- CA
- Correspondent
- Garnette Sutherland
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-12-07 |
Proprietary Names
Smartforceps System
Establishment Types
Manufacture Medical Device