FDA Registration Active 🇨🇷 Costa Rica

Arthocare8208 (CR2) - BIRAPTR 2.3 PK SUTR ANCR ONE 38 C/B BL

Reg #: 3010273872 · FEI: 3010273872 · Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Synergy Health AST, SRL
Registration Number
3010273872
FEI Number
3010273872
Status
Active
Expiry Year
2025
Initial Importer
No
Address
B13.1 Street 4, Avenue 1, Coyol Free Zone
City
Alajuela
Country
CR

Regulatory Submissions

510(k) Number
K071586

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 Road
City
Mentor
State
OH
ZIP
44060
Country
US
Phone
440 3927490

Products

Device Name Product Code
Fastener, Fixation, Nondegradable, Soft Tissue MBI

Proprietary Names

Arthocare8208 (CR2) - BIRAPTR 2.3 PK SUTR ANCR ONE 38 C/B BL Arthocare8208 (CR2) - BIRPTR 2.3 PK SUT ANCHR W/ ULTRAB BLK Arthocare8208 (CR2) - BIORPTR 2.3 PK SUTR ANCR ONE 38 C/B BK Arthocare8208 (CR2) - BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB Arthocare8208 (CR2) - BIRPTR 2.3 PK SUT ANCHR W/ ULTRAB WTE Arthocare8208 (CR2) - RAPTORMITE 3 PK W/NDL 2 0 ULTRABRA

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)