Identity
- Trade Name
- INDIBA ACTIV - CT9 FDA UDI
- Generic Name
- Medium-wave diathermy treatment system FDA UDI
- Device Name
- Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories FDA UDI
- Model / Reference
- ACT0309USA FDA UDI
- Description
- Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories FDA UDI
Identifiers
- Catalog Number
- ACT0309USA FDA UDI
- Primary DI / UDI-DI
- 08434251000229 FDA UDI
- 510(k) Number
- K161458 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Medium-wave diathermy treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Indiba Activ - Ct9 by Indiba Sa. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K161458 also covers:
- INDIBA ACTIV - ACTIV 701 — INDIBA SA.
- INDIBA ACTIV - ACTIV 801 — INDIBA SA.
- INDIBA ACTIV - ACTIV 902 — INDIBA SA.
- INDIBA ACTIV - AT7 — INDIBA SA.
- INDIBA ACTIV - CT7 — INDIBA SA.
- INDIBA ACTIV - CT8 — INDIBA SA.
- INDIBA DEEP CARE - ELITE — INDIBA SA.
- INDIBA DEEP CARE - ELITE NS — INDIBA SA.
- INDIBA DEEP CARE - PREMIUM — INDIBA SA.
- INDIBA DEEP CARE - PREMIUM NS — INDIBA SA.
- INDIBA DEEP CARE - RGN — INDIBA SA.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Indiba Sa.
Sources (1)
- FDA UDI 782bfac5-3af1-4b37-aabe-bf78784c0d3c 36 fields · synced May 30, 2026