WISONIC
GUDID 06971355420758
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Rectal/vaginal ultrasound imaging transducer| Primary Device ID | 06971355420758 |
| NIH Device Record Key | 60b8e531-e820-4c4a-a14e-29f63f89f94c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WISONIC |
| Version Model Number | EV11-3-H |
| Company DUNS | 543063066 |
| Company Name | SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06971355420758 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210154
FDA Product Code
| ITX | Transducer, Ultrasonic, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-30 |
| Device Publish Date | 2021-08-20 |
On-Brand Devices [WISONIC]
| 06971355420260 | L10-5 |
| 06971355420253 | G60 |
| 06971355420246 | Piloter |
| 06971355420215 | G100 |
| 06971355420178 | L15-4NB |
| 06971355420154 | L15-4 |
| 06971355420147 | EV10-4 |
| 06971355420109 | C5-2B |
| 06971355420093 | C5-2 |
| 06971355420079 | C5-1 |
| 06971355420024 | Clover 60 |
| 06971355420277 | C7-3 |
| 06971355420017 | Clover 50 |
| 06971355420321 | LI14I06A |
| 06971355420611 | Labat PE |
| 06971355420581 | Labat SE |
| 06971355420765 | P7-3T-H |
| 06971355420758 | EV11-3-H |
| 06971355420741 | SP5-1-H |
| 06971355420734 | L15-4WB-H |
| 06971355420727 | C8-3-H |
| 06971355420710 | L15-4NB-H |
| 06971355420703 | L22-10-H |
| 06971355420697 | LH15-6-H |
| 06971355420680 | C6-1B-H |
| 06971355420673 | L15-6-H |
| 06971355420666 | Labat IG |
| 06971355420659 | Labat IE |
| 06971355420642 | Labat TG |
| 06971355420635 | Labat TE |
| 06971355420628 | Labat PG |
| 06971355420604 | Labat SG |
| 06971355420598 | Labat SP |
| 06971355420338 | LI14I13A |
Trademark Results [WISONIC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WISONIC 86777493 5030250 Live/Registered |
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. 2015-10-04 |
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