DEVICE: NeuroTherm™ (05415067021571)

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Device Identifier (DI) Information

NeuroTherm™
RFDE-10
RFDE-10
NEUROTHERM, INC.
05415067021571
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, single-use A sterile, semi-flexible, hand-held surgical instrument designed to connect to a radio-frequency (RF) ablation system generator to deliver RF energy to a targeted operative site for soft-tissue ablation (i.e., thermal ablation, therapeutic lesion, or denervation). It includes multiple monopolar electrodes that extend from its tip, once deployed, for application to the treatment site; the electrodes typically include temperature-sensing elements. The device is intended to be used in percutaneous, laparoscopic, or open surgery procedures to ablate tissue typically in the brain/nerves, liver, and/or in small or metastatic tumours. This is a single-use device.
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FDA Product Code

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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 a cool dry place; avoid exposure to extreme temperatures.
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Clinically Relevant Size

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Size Type Text
Length: 10 Centimeter
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Device Status

In Commercial Distribution
October 30, 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
15415067021578 5 05415067021571 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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