FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuroTherm™
DI: 05415067021847
·
Model: SMK
·
NEUROTHERM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroTherm™
- Primary DI
- 05415067021847
- Version / Model
- SMK
- Catalog Number
- SMK-S1505-20
- Company Name
- NEUROTHERM, INC.
- Labeler DUNS
- 124023552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-10
- Public Version
- 5
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 88113f7f-f488-49b8-8b69-ec795ee266ba
Device Description
Radiofrequency Cannula - Straight
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
- 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 | 15415067021844 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 05415067021847 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042375 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15 | Centimeter | |
| Needle Gauge | 20 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.