FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuroTherm™
DI: 05415067021137
·
Model: NRFE-10
·
NEUROTHERM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroTherm™
- Primary DI
- 05415067021137
- Version / Model
- NRFE-10
- Catalog Number
- NRFE-10
- Company Name
- NEUROTHERM, INC.
- Labeler DUNS
- 124023552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-30
- Public Version
- 3
- Public Version Date
- 2023-08-15
- Public Version Status
- Update
- Public Device Record Key
- 0546e0f9-04ae-411a-a5f2-e4af747f8770
Device Description
Reusable Radiofrequency Electrode
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXI | PROBE, RADIOFREQUENCY LESION | Neurology | 882.4725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62025 | Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable | A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067021137 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place; avoid exposure to extreme temperatures.