Is this your brand? Sign in to claim ownership.
Sign in to claim this brandUnilene Sac
US
Last updated May 23, 2026
What Unilene Sac makes
The company manufactures various types of surgical sutures, including bioabsorbable and non-bioabsorbable varieties made from polyester, polyolefin/fluoropolymer, silk, and nylon. These sutures are available in monofilament and multifilament forms, with some designed for non-antimicrobial use. Additionally, they produce bioabsorbable surgical support tape for wound closure and stabilization.
All listed devices fall under FDA Class II regulation and are authorised through the 510(k) pathway and the Unique Device Identifier (UDI) system. The company’s products are registered in the FDA’s regulatory databases, ensuring compliance with US medical device standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (224)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sutumed | SDNN010MC360 | FDA UDI | Class II | Active |
| Sutumed | SDNN050MC160 | FDA UDI | Class II | Active |
| Sutumed | SDST010TC300 | FDA UDI | Class II | Active |
| Sutumed | SDAG001MR360 | FDA UDI | Class II | Active |
| Sutumed | SDAG050TC130 | FDA UDI | Class II | Active |
| Sutumed | SDPP060TC160 | FDA UDI | Class II | Active |
| Sutumed | SDPG020TC240 | FDA UDI | Class II | Active |
| Sutumed | SDPP001MC360 | FDA UDI | Class II | Active |
| Sutumed | SDPP020MC260 | FDA UDI | Class II | Active |
| Sutumed | SDNL040TC130 | FDA UDI | Class II | Active |
| Sutumed | SDAG030MC260 | FDA UDI | Class II | Active |
| Sutumed | SDPP050TC160 | FDA UDI | Class II | Active |
| Sutumed | SDAG040TC130 | FDA UDI | Class II | Active |
| Sutumed | SDAG050TC160 | FDA UDI | Class II | Active |
| Sutumed | SDST020TC260 | FDA UDI | Class II | Active |
| Sutumed | SDPP030TC190 | FDA UDI | Class II | Active |
| Sutumed | SDAG001MR260 | FDA UDI | Class II | Active |
| Sutumed | SDAG001MR400 | FDA UDI | Class II | Active |
| Sutumed | SDPP060TC190 | FDA UDI | Class II | Active |
| Sutumed | SDST030MR260 | FDA UDI | Class II | Active |
| Sutumed | SDPP070TS093 | FDA UDI | Class II | Active |
| Sutumed | SDPP030RC600 | FDA UDI | Class II | Active |
| Vital Sutures Suturex Cirugia Peruana Sutumed | K123034 | FDA 510(k) | Class II | Active |
| Vital Sutures, Suturex, Cirugia Peruana | K100780 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Unilene, Sac Lima Lima (Region) · PE FEI 3004845555