FDA Registration Active 🇮🇹 Italy

TRUGLYDE ABSORBABLE SURGICAL SUTURE U.S.P. (Braided and Coated Polyglycolic Acid)

Reg #: 3006680097 · FEI: 3006680097 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
THD SPA
Registration Number
3006680097
FEI Number
3006680097
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Via per Carpi, 15/B
City
Correggio Reggio Emilia
Country
IT

Regulatory Submissions

510(k) Number
K041515

Owner / Operator

Firm Name
THD SpA
Operator Number
10025818
Address
Via per Carpi, 15/B
City
Correggio
State
Reggio Emilia
Postal Code
42015
Country
IT
Correspondent
Filippo Bastia

US Agent

Business Name
THD America Inc.
Contact Name
Filippo bastia
Address
1731 SE Oralabor Road
City
Ankeny
State
IA
ZIP
50021
Country
US
Phone
866 3749442

Products

Device Name Product Code
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM

Proprietary Names

TRUGLYDE ABSORBABLE SURGICAL SUTURE U.S.P. (Braided and Coated Polyglycolic Acid)

Establishment Types

Export Device to the United States But Perform No Other Operation on Device