DEVICE: NeuroTherm™ (05415067021762)

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Device Identifier (DI) Information

NeuroTherm™
SL
SL-C1510-18
NEUROTHERM, INC.
05415067021762
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Radio-frequency ablation system probe cannula, single-use A sterile rigid tube designed to provide body tissue access through its lumen for a radio-frequency (RF) probe during 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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FDA Product Code

[?]
Product Code Product Code Name
GXI PROBE, RADIOFREQUENCY LESION
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in cool, dry place, avoid extreme temperatures
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 18 Gauge
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Device Status

In Commercial Distribution
July 31, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15415067021769 10 05415067021762 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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