FDA Registration
Active
🇧🇷 Brazil
Harmonic Ace Curved Shears
Reg #: 3014663814
·
FEI: 3014663814
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- H. Strattner
- Registration Number
- 3014663814
- FEI Number
- 3014663814
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Tucunare Avenue - 550, 5, Andar - Alphaville
- City
- Barueri Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K093217
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 |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2010-09-21 |
Proprietary Names
Harmonic Ace Curved Shears
Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si
5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000)
Harmonic Ace Curved Shears , 5mm, da Vinci S, Si
Harmonic Ace Curved Shears , 8mm, da Vinci S, Si
Harmonic Ace Curved Shears , 5mm, da Vinci
Establishment Types
Export Device to the United States But Perform No Other Operation on Device