INDIBA DEEP CARE - REVERSO - Tip 176 pins REVERSO tip 176 pins

GUDID 18434251002725

Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to be treated in a functional manner.

INDIBA SA.

Intradermal radio-frequency ablation system
Primary Device ID18434251002725
NIH Device Record Key9d9bac12-d388-4786-93d4-9c567d275711
Commercial Distribution StatusIn Commercial Distribution
Brand NameINDIBA DEEP CARE - REVERSO - Tip 176 pins
Version Model NumberACC1017USA
Catalog NumberREVERSO tip 176 pins
Company DUNS460060916
Company NameINDIBA SA.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS118434251002725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


[18434251002725]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-13
Device Publish Date2023-06-05

Devices Manufactured by INDIBA SA.

08434251003084 - INDIBA DEEP CARE - EVONY2025-02-14 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Evony device is intended to
08434251003640 - INDIBA ACTIV - ACTIV CT92025-02-14 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Activ CT9 device is intended
08434251000229 - INDIBA ACTIV - CT92025-02-07 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories
08434251002636 - INDIBA DEEP CARE - REVERSO2023-06-13 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
08434251002667 - INDIBA DEEP CARE - REVERSO - Applicator handle2023-06-13 Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips.
18434251002640 - INDIBA DEEP CARE - REVERSO - Tip 80 pins2023-06-13 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 pins2023-06-13 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 pins2023-06-13 Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to b

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.