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
- [email protected]
- Phone
- 866 3749442
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2017-07-12 |
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