DEVICE: NeuroTherm™ (05415067022127)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
No | |
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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? |
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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 |
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GXI | PROBE, RADIOFREQUENCY LESION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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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Needle Gauge: 20 Gauge |
Device Record Status
bd62294e-8d0c-404d-9f4f-9d19afdb08c5
May 03, 2023
4
September 14, 2015
May 03, 2023
4
September 14, 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 |
---|---|---|---|---|---|
15415067022124 | 10 | 05415067022127 | 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