DEVICE: NeuroTherm™ (05415067022394)
Device Identifier (DI) Information
NeuroTherm™
RFDEUK-5
Not in Commercial Distribution
RFDEUK-5
NEUROTHERM, INC.
RFDEUK-5
Not in Commercial Distribution
RFDEUK-5
NEUROTHERM, INC.
Disposable Radiofrequency Electrode
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61931 | Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use |
A hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under external image guidance or using electrical stimulation for nerve location] 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 or a tubing set to allow fluid cooling of the electrode may be included. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GXI | PROBE, RADIOFREQUENCY LESION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in a cool dry place; avoid exposure to extreme temperatures. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 5 Centimeter |
Device Record Status
c7678ed1-13cb-404d-94a0-dfa374005ded
August 16, 2023
3
October 30, 2015
August 16, 2023
3
October 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
15415067022391 | 10 | 05415067022394 | 2020-04-02 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com