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
Phone
440 3927490

Products

Device Name Product Code
Electrosurgical, Cutting & Coagulation & Accessories GEI

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)