FDA Registration
Active
🇺🇸 United States
QuickTork Guidewire Torque Device (010"-020") (TOR-100-10)
Reg #: 1649395
·
FEI: 3000718472
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GALT MEDICAL CORP.
- Registration Number
- 1649395
- FEI Number
- 3000718472
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2220 Merritt Dr
- City
- GARLAND
- State
- TX
- ZIP
- 75041
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143252
Owner / Operator
- Firm Name
- Theragenics Corporation
- Operator Number
- 1037598
- Address
- 5203 BRISTOL INDUSTRIAL WAY, --
- City
- Buford
- State
- GA
- Postal Code
- 30518
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2015-12-24 |
Proprietary Names
QuickTork Guidewire Torque Device (010"-020") (TOR-100-10)
QuickTork Guidewire Torque Device (025"-040") (TOR-100-25)
Establishment Types
Manufacture Medical Device