FDA Registration
Active
🇺🇸 United States
FMWAND FERROMAGNETIC SURGICAL SYSTEM
Reg #: 3005350457
·
FEI: 3005350457
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Omni-Guide Holdings, Inc.
- Registration Number
- 3005350457
- FEI Number
- 3005350457
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 43 Manning Road
- City
- Billerica
- State
- MA
- ZIP
- 01821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130606
Owner / Operator
- Firm Name
- OMNIGUIDE, INC.
- Operator Number
- 9070939
- Address
- 43 Manning Rd
- City
- Billerica
- State
- MA
- Postal Code
- 01821
- Country
- US
- Correspondent
- Carlos O Acosta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocautery, Gynecologic (And Accessories) | HGI | Class 2 | Obstetrics/Gynecology | No | 2021-07-14 |
Proprietary Names
FMWAND FERROMAGNETIC SURGICAL SYSTEM
Establishment Types
Manufacture Medical Device