FDA Registration
Active
🇵🇪 Peru
Da Vinci Handheld Camera
Reg #: 3026606306
·
FEI: 3026606306
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ALEM
- Registration Number
- 3026606306
- FEI Number
- 3026606306
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Carretera Panamericana Sur Km. 38
- City
- Distrito de Punta Hermosa Lima
- Country
- PE
Regulatory Submissions
- 510(k) Number
- K191043
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 | 2019-07-18 |
Proprietary Names
Da Vinci Handheld Camera
Handheld Camera Light Guide Adapter
Handheld Camera Sterilization Tray
Handheld Camera Light Guide
Establishment Types
Export Device to the United States But Perform No Other Operation on Device