FDA Registration
Active
🇵🇪 Peru
UNILENE, SAC
Reg #: 3004845555
·
FEI: 3004845555
·
Expires 2026
Products
11
Proprietary Names
12
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- UNILENE, SAC
- Registration Number
- 3004845555
- FEI Number
- 3004845555
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2020-04-27 |
| Device, Rebreathing | BYW | Class 1 | Anesthesiology | No | 2020-04-27 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2011-01-25 |
| Suture, Absorbable, Synthetic | GAN | Class 2 | General, Plastic Surgery | No | 2011-01-25 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2011-01-25 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2020-05-06 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-06 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2013-06-04 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2013-06-04 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2013-06-04 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2020-04-27 |
Proprietary Names
Ventury Low Concentration Oxygen Mask Sutumed, Gamed, U-Mask, Cirugia Peruana
Rebreathing - Non-rebreathing Oxygen Mask Sutumed, Gamed, U-Mask, Cirugia Peruana
Polyglecaprone - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Polyglicolic Acid - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Polyglactin - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Polydioxanone - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Protection Shield - Protection Mask Sutumed, Gamed, U-Mask, Cirugia Peruana
Medical Mask - Sutumed, Gamed, U-Mask, Cirugia Peruana
Silk - Nonabsorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Polypropylene - Synthetic Nonasorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Monofilament Nylon - Synthetic Nonabsorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus
Oxygen Mask Sutumed, Gamed, U-Mask, Cirugia Peruana
Establishment Types
Manufacture Medical Device