FDA Registration
Active
🇺🇸 United States
Bayer1673 (SX) - MEDRAD 150mL FasTurn Sterile Disposable Syringe with QFT
Reg #: 3009882464
·
FEI: 3009882464
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Synergy Health AST, LLC
- Registration Number
- 3009882464
- FEI Number
- 3009882464
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7225 N Noah Dr
- City
- Saxonburg
- State
- PA
- ZIP
- 16056
- Country
- US
Regulatory Submissions
- 510(k) Number
- K822536
Owner / Operator
- Firm Name
- Synergy Health AST, LLC
- Operator Number
- 10028672
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2016-07-21 |
Proprietary Names
Bayer1673 (SX) - MEDRAD 150mL FasTurn Sterile Disposable Syringe with QFT
Bayer1673 (SX) - MEDRAD 200mL FasTurn Sterile Disposable Syringe
Bayer1673 (SX) - MEDRAD 150mL FasTurn Sterile Disposable Syringe
Bayer1673 (SX) - MEDRAD 200mL FasTurn Sterile Disposable Syringe with QFT
Bayer1673 (SX) -ProVis 200 mL FasTurn Sterile Disposable Syringe (200-FT)
Bayer1675 (SX) -MEDRAD Mark V ProVis 200 mL FasTurn Sterile Disposable Syringe & QFT
Bayer1675 (SX) - MEDRAD Mark V ProVis 200 mL FasTurn Sterile Disposable Syringe & QFT
Bayer1673 (SX) - Sterile Disposable Syringe 150 mL & QFT
Bayer1673 (SX) - 200 mL FasTurn Sterile Disposable Syringe & QFT
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)