INDIBA ACTIV - CT9 ACT0309USA

GUDID 08434251000229

Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories

INDIBA SA.

Medium-wave diathermy treatment system

• Primary Device ID: 08434251000229
• NIH Device Record Key: 782bfac5-3af1-4b37-aabe-bf78784c0d3c
• Commercial Distribution Discontinuation: 2025-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INDIBA ACTIV - CT9
• Version Model Number: ACT0309USA
• Catalog Number: ACT0309USA
• Company DUNS: 460060916
• Company Name: INDIBA SA.
• Device Count: 1
• DM Exempt: true
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08434251000229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161458

FDA Product Code

• PBX: Massager, vacuum, radio frequency induced heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-02-07
• Device Publish Date: 2019-02-06

Devices Manufactured by INDIBA SA.

• 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: 2025-02-07Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories
• 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
• 18434251002718 - INDIBA DEEP CARE - REVERSO - Tip 88 pins: 2023-06-13 Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to b