FDA Registration
Active
🇦🇺 Australia
Camera Starter Kit
Reg #: 3010885402
·
FEI: 3010885402
·
Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Device Technologies Australia
- Registration Number
- 3010885402
- FEI Number
- 3010885402
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 158 Hollinsworth Road
- City
- Marsden Park New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K081137
Owner / Operator
- Firm Name
- Intuitive Surgical, Inc.
- Operator Number
- 9028901
- Address
- 1266 Kifer Road, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94086
- Country
- US
- Correspondent
- Mario Lowe
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2009-12-07 |
Proprietary Names
Camera Starter Kit
12 mm Endoscope, 0°
ASSY,PSCART,IS3000,4-ARM
ASSY,PSCART,IS3000,3-ARM
ASSY,SSC,IS3000
3DHD Camera Head and Cable
CABLE KIT,BLUE FIBERCONNECT,20M
Accessory Base Starter Kit
KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F
Energy Activation Cable, ERBE, da Vinci Si
Energy Activation Cable, CONMED, da Vinci Si
VisionBoom¿ Extension Cable
Energy Activation Cable, Valleylab, da Vinci Si
Option, Connect, da Vinci Si
VIO-ICB Mounting Bracket
da Vinci Surgical System, Si
Cannula Seal, 8mm
12 mm Endoscope, 30°
Energy Activation Adapter, Ethicon GEN11, da Vinci Si
Energy Activation Cable, Ethicon, da Vinci Si
Energy Activation Cable, Gyrus, da Vinci Si
ASSY,VSS VISION SYSTEM W/AVP,VS3000
Establishment Types
Export Device to the United States But Perform No Other Operation on Device