FDA Registration
Active
🇦🇺 Australia
Endoscope Sterilization Tray
Reg #: 3010885402
·
FEI: 3010885402
·
Expires 2025
Products
1
Proprietary Names
1
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
- K183139
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 |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2019-06-13 |
Proprietary Names
Endoscope Sterilization Tray
Establishment Types
Export Device to the United States But Perform No Other Operation on Device