FDA Registration
Active
🇵🇪 Peru
Polyglecaprone - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Reg #: 3004845555
·
FEI: 3004845555
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- UNILENE, SAC
- Registration Number
- 3004845555
- FEI Number
- 3004845555
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Napo No. 450
- City
- Lima Lima (Region)
- Country
- PE
Regulatory Submissions
- 510(k) Number
- K100780
Owner / Operator
- Firm Name
- Unilene, SAC
- Operator Number
- 10035000
- Address
- Napo No. 450
- City
- Lima
- State
- Lima (Region)
- Postal Code
- 15082
- Country
- PE
- Correspondent
- Martha Lujan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Absorbable, Synthetic | GAN | Class 2 | General, Plastic Surgery | No | 2011-01-25 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2011-01-25 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2011-01-25 |
Proprietary Names
Polyglecaprone - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Polyglicolic Acid - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Polydioxanone - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Polyglactin - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Establishment Types
Manufacture Medical Device