DermaFuse DER0110
GUDID 07290016746495
DermaFuse console
VIORA LTD
Transcutaneous electrical stimulation lead| Primary Device ID | 07290016746495 |
| NIH Device Record Key | 18cb4335-64cc-44b8-9662-7d11f66a6a35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DermaFuse |
| Version Model Number | DER0110 |
| Catalog Number | DER0110 |
| Company DUNS | 514612758 |
| Company Name | VIORA LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016746495 [Primary] |
FDA Product Code
| ISA | Massager, Therapeutic, Electric |
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 | 2025-05-29 |
| Device Publish Date | 2025-05-21 |
Devices Manufactured by VIORA LTD
| 07290016746464 - V-ST Single Use tip | 2025-09-09 V-ST Single Use tip |
| 07290016746471 - V-VR Handpiece | 2025-09-09 V-VR Handpiece |
| 17290016746652 - V-FC Tip | 2025-09-09 V-FC Tip |
| 07290016746785 - V-FC Pro Full | 2025-09-09 Kit of V-FC Pro Handpiece, V-FC Pro Tips and maintenance kit |
| 07290016746808 - V-FC Pro Tip | 2025-09-09 |
| 07290016746815 - V-FC Pro Handpiece | 2025-09-09 |
| 07290016746716 - Console | 2025-07-31 EnerJet Console |
| 07290016746723 - Applicator | 2025-07-31 EnerJet Applicator |
Trademark Results [DermaFuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DERMAFUSE 97482138 not registered Live/Pending |
Millpledge Limited 2022-06-29 |
 DERMAFUSE 88673153 not registered Live/Pending |
Viora Ltd 2019-10-29 |
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