INDIBA DEEP CARE - REVERSO - Applicator handle REVERSO applicator handle

GUDID 08434251002667

Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips.

INDIBA SA.

Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system Intradermal radio-frequency ablation system

• Primary Device ID: 08434251002667
• NIH Device Record Key: 7a556242-931a-4f7e-97bd-48214573383e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INDIBA DEEP CARE - REVERSO - Applicator handle
• Version Model Number: ACC1018USA
• Catalog Number: REVERSO applicator handle
• 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	08434251002667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212107

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: 2023-06-13
• Device Publish Date: 2023-06-05

Devices Manufactured by INDIBA SA.

• 08434251002636 - INDIBA DEEP CARE - REVERSO: 2023-06-13 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
• 08434251002667 - INDIBA DEEP CARE - REVERSO - Applicator handle: 2023-06-13Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips.
• 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
• 18434251002725 - INDIBA DEEP CARE - REVERSO - Tip 176 pins: 2023-06-13 Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to b
• 18434251002831 - INDIBA DEEP CARE - REVERSO - Tip 44 pins: 2023-06-13 Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to b
• 08434251000915 - INDIBA ACTIV - AT7: 2021-04-14 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories