FDA UDI
In Commercial Distribution
🇺🇸 United States
RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder)
DI: 08058341213919
·
Model: RF0MXXYYYRZZA
·
ITALIAN ENGINEERING SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder)
- Primary DI
- 08058341213919
- Version / Model
- RF0MXXYYYRZZA
- Company Name
- ITALIAN ENGINEERING SRL
- Labeler DUNS
- 431954955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-28
- Public Version
- 2
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 6713929c-7da6-4ddf-bdf3-ef9cb96fddd7
Device Description
RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm with Holder. This includes: - RF0M22050R10A - RF0M22100R10A - RF0M20150R10A - RF0M16200R10A. Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. To be used only with ATTIVA device (K220505).
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 08058341213919 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220505 | 000 |