DEVICE: NeuroTherm™ (05415067021847)
Device Identifier (DI) Information
NeuroTherm™
SMK
In Commercial Distribution
SMK-S1505-20
NEUROTHERM, INC.
SMK
In Commercial Distribution
SMK-S1505-20
NEUROTHERM, INC.
Radiofrequency Cannula - Straight
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? |
---|---|---|---|---|
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.
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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 [?] |
---|---|
K042375 | 000 |
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. Do not use if package is damaged. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 15 Centimeter |
Needle Gauge: 20 Gauge |
Device Record Status
88113f7f-f488-49b8-8b69-ec795ee266ba
May 03, 2023
5
May 10, 2016
May 03, 2023
5
May 10, 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 |
---|---|---|---|---|---|
15415067021844 | 10 | 05415067021847 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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