FDA Registration
Active
🇨🇱 Chile
8 mm Trocar, Standard
Reg #: 3013077751
·
FEI: 3013077751
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BOMI
- Registration Number
- 3013077751
- FEI Number
- 3013077751
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Camino de Noviciado 3707 Modulo 1, Pudahuel
- City
- Santiago Region Metropolitana
- Country
- CL
Regulatory Submissions
- 510(k) Number
- K133845
Owner / Operator
- Firm Name
- Intuitive Surgical, Inc.
- Operator Number
- 9028901
- Address
- 1266 Kifer Road, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94086
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2014-03-10 |
Proprietary Names
8 mm Trocar, Standard
8 mm Trocar, Long
5 mm to 8 mm Cannula Seal
Establishment Types
Export Device to the United States But Perform No Other Operation on Device