FDA UDI
In Commercial Distribution
🇺🇸 United States
INDIBA ACTIV - ACTIV CT9
DI: 08434251003640
·
Model: ACT0309
·
INDIBA SA.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INDIBA ACTIV - ACTIV CT9
- Primary DI
- 08434251003640
- Version / Model
- ACT0309
- Catalog Number
- ACT0309BLKUSA
- Company Name
- INDIBA SA.
- Labeler DUNS
- 460060916
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-06
- Public Version
- 1
- Public Version Date
- 2025-02-14
- Public Version Status
- New
- Public Device Record Key
- 173ed5cb-89e2-454b-8c82-78fa40eccfd9
Device Description
Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Activ CT9 device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBX | Massager, vacuum, radio frequency induced heat | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47575 | Medium-wave diathermy treatment system | An assembly of devices designed to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. The system is commonly used in outpatient, rehabilitation, traumatology, and sports centre settings to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08434251003640 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241107 | 000 |