FDA Registration
Active
🇨🇷 Costa Rica
Arthocare8208 (CR1) - Right Angle 90 3.5mm 90 ICW
Reg #: 3007738736
·
FEI: 3007738736
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Synergy Health AST, SRL
- Registration Number
- 3007738736
- FEI Number
- 3007738736
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- B16 Street 4, Avenue 0, Coyol Free Zone
- City
- Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K033584
Owner / Operator
- Firm Name
- Synergy Health AST, LLC
- Operator Number
- 10028672
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health AST, LLC
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2012-10-31 |
Proprietary Names
Arthocare8208 (CR1) - Right Angle 90 3.5mm 90 ICW
Arthocare8208 (CR1) - Dome 60 2.5mm 60
Arthocare8208 (CR1) - MENIVAC 45 3mm 45 Suction
Arthocare8208 (CR1) - Bevel 45 3mm 45 ICW
Arthocare8208 (CR1) - SABER 30 3mm 30 ICW
Arthocare8208 (CR1) -COVAC 50
Arthocare8208 (CR1) -COVAC 70
Arthocare8208 (CR1) - Super MULTIVAC 50 3.75mm 50 Suction
Arthocare8208 (CR1) - MULTIVAC 50 XL 3.75mm 50 Suction
Arthocare8208 (CR1) - ELIMINATOR 90 4.5mm 90 ICW
Arthocare8208 (CR1) - MICROBLATOR 30 1.4mm 30
Arthocare8208 (CR1) - CAPSURE 30 3mm 30
Arthocare8208 (CR1) - LOPRO 90 3.6mm 90 ICW
Arthocare8208 (CR1) -TRISTAR 50 3mm 50 Suction ICW
Arthocare8208 (CR1) - Short Bevel 35 2.3mm 35 ICW
Arthocare8208 (CR1) - TURBOVAC 90 XL
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)