FDA UDI
In Commercial Distribution
🇺🇸 United States
RFTL Sono
DI: 04048223131169
·
Model: 001175-20B
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- RFTL Sono
- Primary DI
- 04048223131169
- Version / Model
- 001175-20B
- Catalog Number
- 001175-20B
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-04
- Public Version
- 1
- Public Version Date
- 2025-11-12
- Public Version Status
- New
- Public Device Record Key
- 332d82c2-49e7-4b29-a254-0429935705b7
Device Description
RFTL Sono 22G x 98,6 mm with Cornerstone reflectors,
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GXI | Probe, radiofrequency lesion | Neurology | 882.4725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58739 | Percutaneous radio-frequency ablation probe cannula, single-use | A rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04048223132548 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 04048223131169 | GS1 | ||||
| Previous | 04048223050514 | GS1 |
Customer Contacts
- Phone
- +1 770-493-6832
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060397 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 65 Percent (%) Relative Humidity