FDA UDI
In Commercial Distribution
🇺🇸 United States
Sonata® System Radiofrequency Generator
DI: 10817929020203
·
Model: RFG2-110
·
GYNESONICS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sonata® System Radiofrequency Generator
- Primary DI
- 10817929020203
- Version / Model
- RFG2-110
- Catalog Number
- RFG2-110
- Company Name
- GYNESONICS, INC.
- Labeler DUNS
- 618493741
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-10
- Public Version
- 1
- Public Version Date
- 2019-05-20
- Public Version Status
- New
- Public Device Record Key
- ea87d0f4-c4e0-482d-8421-bd912a80ca2b
Device Description
Ultrasound-guided intrauterine electrosurgical system generator
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
- 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 |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Obstetrics/Gynecology | 884.4160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58488 | Ultrasound-guided intrauterine radio-frequency ablation system generator | A mains electricity (AC-powered) component of an ultrasound-guided intrauterine radio-frequency ablation system designed to generate a high frequency electrical current in selected radio-frequency (RF) bands between two electrodes to produce heat directly within soft-tissue cells for intrauterine ablation of uterine fibroids; the RF energy is delivered to the site of intervention via a dedicated handpiece and electrode. It also typically provides continuous tissue temperature monitoring, and impedance and power monitoring with tissue overheating safety systems. It is configured with dedicated application software and includes user interface/controls and inputs for other system components. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10817929020203 | GS1 |
Customer Contacts
- Phone
- 650-216-3860
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173703 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 45 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity