NeuroTherm™ RFDE-20
GUDID 15415067021615
Disposable Radiofrequency Electrode
NEUROTHERM, INC.
Percutaneous electrosurgical probe, denervation, monopolar, single-use| Primary Device ID | 15415067021615 |
| NIH Device Record Key | bbce7341-e2d9-4c2c-86aa-a58f02629de1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroTherm™ |
| Version Model Number | RFDE-20 |
| Catalog Number | RFDE-20 |
| Company DUNS | 124023552 |
| Company Name | NEUROTHERM, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067021618 [Primary] |
| GS1 | 15415067021615 [Package] Contains: 05415067021618 Package: [5 Units] In Commercial Distribution |
FDA Product Code
| GXI | PROBE, RADIOFREQUENCY LESION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2016-05-10 |
On-Brand Devices [NeuroTherm™]
Trademark Results [NeuroTherm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROTHERM 76063816 2575296 Live/Registered |
NEUROTHERM INC. 2000-06-06 |
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