FDA UDI
In Commercial Distribution
🇺🇸 United States
Serene Medical
DI: B653RFG100TC0
·
Model: RFG-100.TC
·
SERENE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Serene Medical
- Primary DI
- B653RFG100TC0
- Version / Model
- RFG-100.TC
- Company Name
- SERENE MEDICAL, INC.
- Labeler DUNS
- 045060651
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-01
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- a2868647-a6f8-426b-a723-b53cab5a9dd2
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
- No
- 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 |
|---|---|---|---|---|
| GXD | Generator, Lesion, Radiofrequency | Neurology | 882.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35156 | Percutaneous radio-frequency ablation system generator | An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B653RFG100TC0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081729 | 000 |