FDA Registration
Active
🇨🇷 Costa Rica
Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix®
Reg #: 3012883202
·
FEI: 3012883202
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ESTABLISHMENT LABS S.A.
- Registration Number
- 3012883202
- FEI Number
- 3012883202
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Coyol Free Zone & Business Park Building, 4th Street, Building B-15
- City
- Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K183163
Owner / Operator
- Firm Name
- Establishment Labs- Motiva USA LLC
- Operator Number
- 10061559
- Address
- 125 E. De la Guerra #203A
- City
- Santa Barbara
- State
- CA
- Postal Code
- 93101
- Country
- US
US Agent
- Business Name
- Motiva USA LLC
- Contact Name
- Rosalyn D'incelli
- Address
- 125 E De La Guerra St Ste 203a
- City
- Santa Barbara
- State
- CA
- ZIP
- 93101
- Country
- US
- [email protected]
- Phone
- 805 4525421
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mammary Sizer | MRD | Class U | Unknown | No | 2019-10-29 |
Proprietary Names
Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix®
Establishment Types
Manufacture Medical Device