Sonicure
GUDID 16972304750473
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Soft-tissue ultrasonic surgical system| Primary Device ID | 16972304750473 |
| NIH Device Record Key | fa1144ee-88b9-443d-8e05-cf53e8a26fc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonicure |
| Version Model Number | SC35C+ |
| Company DUNS | 550274579 |
| Company Name | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 16972304750473 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212614
FDA Product Code
| LFL | Instrument, Ultrasonic Surgical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
[16972304750473]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-03 |
| Device Publish Date | 2022-10-26 |
On-Brand Devices [Sonicure]
| 16972304752828 | TG-A |
| 16972304750480 | SC43C+ |
| 16972304750473 | SC35C+ |
| 16972304750466 | SC21C+ |
| 16972304750459 | SC13C+ |
| 16972304750329 | SC100T |
| 06972304750315 | SC100E |
Trademark Results [Sonicure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONICURE 90512744 not registered Live/Pending |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. 2021-02-05 |
 SONICURE 78632844 3166622 Dead/Cancelled |
Eilrich, John W. 2005-05-18 |
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