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

• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com
• Phone: 888 415 1192
• Email: CustomerCareUsa@sinclair.com

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

• 07290016746495 - DermaFuse: 2025-05-29DermaFuse console
• 07290016746495 - DermaFuse: 2025-05-29 DermaFuse console
• 07290016746679 - Brush Single-Use Tip: 2025-05-29 Brush Single-Use Tip for use with Dermafuse
• 07290016746686 - Flat Single-Use Tip: 2025-05-29 Flat Single-Use Tip for use with Dermafuse
• 07290016746006 - V30 Console: 2018-07-06 V30 Console
• 07290016746013 - V20 Console: 2018-07-06 V20 Console
• 07290016746020 - V10 Console: 2018-07-06 V10 Console
• 07290016746037 - V- IPL Handpiece: 2018-07-06 V- IPL Handpiece
• 07290016746044 - V-IPL HP Basic: 2018-07-06 V-IPL HP Basic