FDA UDI
In Commercial Distribution
🇺🇸 United States
RFT Electrode
DI: 08809559960283
·
Model: RFTP-0705LN
·
RF Medical Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RFT Electrode
- Primary DI
- 08809559960283
- Version / Model
- RFTP-0705LN
- Company Name
- RF Medical Co.,Ltd.
- Labeler DUNS
- 690514869
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-06
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 65c03188-3501-4554-b8ad-15ac34e788a5
Device Description
The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61933 | Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar | A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809559960283 | GS1 |
Customer Contacts
- Phone
- +82221084200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180999 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 7 | Centimeter | |
| Catheter Working Length | 5 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 45 – 65 Percent (%) Relative Humidity