REVERSO PRO SYSTEM IDC0410USA

GUDID 08434251004173

Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.

INDIBA SA.

Intradermal radio-frequency ablation system

• Primary Device ID: 08434251004173
• NIH Device Record Key: 36393558-76ce-41bd-9766-62e307a73eaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVERSO PRO SYSTEM
• Version Model Number: IDC0410
• Catalog Number: IDC0410USA
• Company DUNS: 460060916
• Company Name: INDIBA SA.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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	08434251004173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243139

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2025-08-08
• Device Publish Date: 2025-07-31

Devices Manufactured by INDIBA SA.

• 08434251004173 - REVERSO PRO SYSTEM: 2025-08-08Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
• 08434251004173 - REVERSO PRO SYSTEM: 2025-08-08 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
• 08434251003084 - INDIBA DEEP CARE - EVONY: 2025-02-14 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Evony device is intended to
• 08434251003640 - INDIBA ACTIV - ACTIV CT9: 2025-02-14 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Activ CT9 device is intended
• 08434251000229 - INDIBA ACTIV - CT9: 2025-02-07 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories
• 08434251002636 - INDIBA DEEP CARE - REVERSO: 2023-06-13 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
• 08434251002667 - INDIBA DEEP CARE - REVERSO - Applicator handle: 2023-06-13 Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips.
• 18434251002640 - INDIBA DEEP CARE - REVERSO - Tip 80 pins: 2023-06-13 Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to b
• 18434251002657 - INDIBA DEEP CARE - REVERSO - Tip 160 pins: 2023-06-13 Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to b