FDA Registration
Active
🇺🇸 United States
219-TXAX-013 Torque Driver
Reg #: 3010052483
·
FEI: 3010052483
·
Expires 2025
Products
1
Proprietary Names
37
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ECA MEDICAL INSTRUMENTS
- Registration Number
- 3010052483
- FEI Number
- 3010052483
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1107 Tourmaline Drive
- City
- Newbury Park
- State
- CA
- ZIP
- 91320
- Country
- US
Owner / Operator
- Firm Name
- ECA Medical Instruments
- Operator Number
- 10042970
- Address
- 1107 Tourmaline Drive
- City
- Newbury Park
- State
- CA
- Postal Code
- 91320
- Country
- US
- Correspondent
- Janice Grace
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2018-12-21 |
Proprietary Names
219-TXAX-013 Torque Driver
214-028 Axial Torque Driver
214-002-A Axial Torque Driver
214-015 Axial Torque Driver
212 Axial Torque Driver
207-014 Torque Limiter
200-010-F Torque Limiter
218 Torque Limiter Series
214 Axial Torque Driver Series
215 Axial Torque Driver Series
207-012 Torque Limiter
Hex Key Series
100934-001 Cap
215-007 Axial Torque Driver
100054-001 HEX Key
218-023 Torque Limiter
218-020 Torque Limiter
215-001 Axial Torque Driver
214-014 Axial Torque Driver
214-012 Axial Torque Driver
100148-002 HEX Key
100052-062 HEX Key
214-006 B Axial Torque Driver
218-029 Torque Limiter
214-023 Axial Torque Driver
214-008 Axial Torque Driver
214-029 Axial Torque Driver
218-027 Torque Limiter
218-031 Torque Limiter
214-027 Axial Torque Driver
214-026 Axial Torque Driver
218-025 Torque Limiter
212-069 Axial Torque Driver
214-003 A Axial Torque Driver
100512-001 HEX Key
212-079 Axial Torque Driver
218-028 Torque Limiter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)