FDA Registration
Active
🇺🇸 United States
Gabriel 3-Way EnFit Valve
Reg #: 1066607
·
FEI: 3003282547
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SYNCRO MEDICAL INNOVATIONS, INC.
- Registration Number
- 1066607
- FEI Number
- 3003282547
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 101 Gateway Dr
- City
- Macon
- State
- GA
- ZIP
- 31210
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201741
Owner / Operator
- Firm Name
- SYNCRO MEDICAL INNOVATIONS, INC.
- Operator Number
- 9045267
- Address
- 101 Gateway Dr
- City
- Macon
- State
- GA
- Postal Code
- 31210
- Country
- US
- Correspondent
- Sabry - Gabriel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2021-02-02 |
Proprietary Names
Gabriel 3-Way EnFit Valve
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility