| Primary Device ID | 10817929020340 |
| NIH Device Record Key | dd340bef-aeaa-43c4-b60f-076bd1393ac6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonata System Software |
| Version Model Number | SW-002 |
| Catalog Number | SW-002 |
| Company DUNS | 618493741 |
| Company Name | GYNESONICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10817929020340 [Primary] |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-15 |
| Device Publish Date | 2020-10-07 |
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| 10817929020036 - Sonata® Intrauterine Ultrasound Probe Return Kit | 2020-10-15 |
| 10817929020166 - Sonata® Procedure Kit | 2020-10-15 Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / elect |