FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sonata® System Software
DI: 10817929020357
·
Model: SW-001
·
GYNESONICS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sonata® System Software
- Primary DI
- 10817929020357
- Version / Model
- SW-001
- Catalog Number
- SW-001
- Company Name
- GYNESONICS, INC.
- Labeler DUNS
- 618493741
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-21
- Public Version
- 2
- Public Version Date
- 2021-05-19
- Public Version Status
- Update
- Public Device Record Key
- bd557c4f-a8c2-4bf5-8ef1-2b60d3ca7df1
- Distribution End Date
- 2020-12-30
Device Description
Ultrasound-guided radio-frequency ablation system software
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Obstetrics/Gynecology | 884.4160 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64353 | Ultrasound-guided radio-frequency ablation system software | A software program intended to be used by a healthcare professional for control of, and data extraction from, an ultrasound-guided radio-frequency ablation system. The software is intended to collect and display ultrasound data in real-time while controlling radio-frequency ablation functions, and may have additional workflow-assistive feature capabilities (e.g., alarms, prompts). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10817929020357 | GS1 |
Customer Contacts
- Phone
- 650-216-3860
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173703 | 000 |