FDA Registration
Active
🇨🇷 Costa Rica
Arthocare8208 (CR1) - PROCISE EZ-View with Integrated Cable (MULS)
Reg #: 3007738736
·
FEI: 3007738736
·
Expires 2025
Products
1
Proprietary Names
27
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
- K202006
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 | 2023-06-29 |
Proprietary Names
Arthocare8208 (CR1) - PROCISE EZ-View with Integrated Cable (MULS)
Arthocare8208 (CR1) - REFLEX ULTRA PTR with Integrated Cable
Arthocare8208 (CR1) - PROCISE MAX with Integrated Cable
Arthocare8208 (CR1) - REFLEX ULTRA 55 with Integrated Cable
Arthocare8208 (CR1) - PROCISE MLW Wand with Integrated Cable
Arthocare8208 (CR1) - REFLEX ULTRA PTR with Integrated Cable (MULS)
Arthocare8208 (CR1) - TURBINATOR Wand (MULS)
Arthocare8208 (CR1) - EXCISE PDW Wand with Integrated Cable
Arthocare8208 (CR1) - EVAC 70 Xtra with Integrated Cable (MULS)
Arthocare8208 (CR1) - TURBINATOR Wand
Arthocare8208 (CR1) - PROCISE XP Wand with Integrated Cable (MULS)
Arthocare8208 (CR1) - REFLEX ULTRA SP with Integrated Cable (MULS)
Arthocare8208 (CR1) - REFLEX ULTRA 45 with Integrated Cable (MULS)
Arthocare8208 (CR1) - PROCISE LW Wand with Integrated Cable (MULS)
Arthocare8208 (CR1) - EVAC 70 HP with Integrated Cable (MULS)
Arthocare8208 (CR1) - REFLEX ULTRA SP with Integrated Cable
Arthocare8208 (CR1) - EVAC 70 Xtra with Integrated Cable
Arthocare8208 (CR1) - REFLEX ULTRA 55 with Integrated Cable (MULS)
Arthocare8208 (CR1) - PROCISE EZ-View with Integrated Cable
Arthocare8208 (CR1) - EVAC 70 HP with Integrated Cable
Arthocare8208 (CR1) - PROCISE MAX with Integrated Cable (MULS)
Arthocare8208 (CR1) - REFLEX ULTRA 45 with Integrated Cable
Arthocare8208 (CR1) - PROCISE EZ Wand with Integrated Cable (MULS)
Arthocare8208 (CR1) - PROCISE XP Wand with Integrated Cable
Arthocare8208 (CR1) - PROCISE MLW Wand with Integrated Cable (MULS)
Arthocare8208 (CR1) - PROCISE LW Wand with Integrated Cable
Arthocare8208 (CR1) - PROCISE EZ Wand with Integrated Cable
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)