Cassini Guidance System
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Basic Information
- Brand Name
- Cassini Guidance System
- Primary DI
- 08720892096401
- Version / Model
- 1.0.0
- Company Name
- Cassini Technologies B.V.
- Labeler DUNS
- 492566474
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-08
- Public Version
- 1
- Public Version Date
- 2023-05-16
- Public Version Status
- New
- Public Device Record Key
- 896f3108-f6ec-4a50-bf1e-d217bbf13072
Device Description
Cassini Guidance System provides guidance assistance to the surgeon during eye surgeries. The device displays real-time non-diagnostic video during eye surgery on a flat panel display device positioned for live visualization by the surgeon and surgical personnel in the operating room. The Cassini Guidance System provides graphical tools to the surgeon as desired during treatment by using pre-operative clinical data and surgeon-driven, onscreen templates and tools. The system utilizes surgeon confirmation at each step to plan and position guidance tools. The system neither performs any interpretations nor provides treatment recommendations.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NFG | Device, Communications, Images, Ophthalmic | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60724 | Multidisciplinary medical image management software | A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720892096401 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 55 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity