FDA Registration
Active
🇺🇸 United States
NeedleTech Products, Inc.
Reg #: 3006283319
·
FEI: 3006283319
·
Expires 2026
Products
6
Proprietary Names
9
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- NeedleTech Products, Inc.
- Registration Number
- 3006283319
- FEI Number
- 3006283319
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 452 John L Dietsch Blvd
- City
- N Attleboro
- State
- MA
- ZIP
- 02763
- Country
- US
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 | 2007-11-20 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-11-20 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2007-11-20 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2008-12-24 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2024-07-17 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2008-12-24 |
Proprietary Names
GUIDEWIRE INTRODUCER NEEDLE
Galt Medical Guidewire
Micro-Access Tearaway
Coaxial
GaltStick
CATHATER NEEDLE
Guidewire
Elite HV
Nitinol Guidewires (Mandrel)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)