DEVICE: NeuroTherm™ (05415067026576)
Device Identifier (DI) Information
NeuroTherm™
PT-KIT-S
In Commercial Distribution
PT-KIT-S
NEUROTHERM, INC.
PT-KIT-S
In Commercial Distribution
PT-KIT-S
NEUROTHERM, INC.
PodiaTherm Disposable Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
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.
|
Active | false |
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.
|
Active | false |
58494 | Electrosurgical return electrode, single-use |
A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GXI | PROBE, RADIOFREQUENCY LESION |
GXD | GENERATOR, LESION, RADIOFREQUENCY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool dry place: avoid exposure to extreme temperatures. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5036c9a7-cfdf-4573-b956-c52a7ab9f4a5
October 06, 2023
7
September 12, 2016
October 06, 2023
7
September 12, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
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