DEVICE: NeuroTherm™ (05415067021199)

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Device Identifier (DI) Information

NeuroTherm™
RFE-15-S
RFE-15-S
NEUROTHERM, INC.
05415067021199
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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, reusable A hand-held surgical device designed to connect to a radio-frequency ablation system generator to deliver radio-frequency (RF) energy to a targeted operative site for soft-tissue coagulation/ablation (i.e., thermal ablation, therapeutic lesion, or denervation). It is intended to be used in percutaneous, laparoscopic, or intraoperative procedures to ablate tissue typically in the brain/nerves, kidney, liver, and/or in small or metastatic tumours. The device typically includes multiple electrodes that extend from its tip, once deployed, and which cover the site to be treated. This is a reusable device.
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FDA Product Code

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

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
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: 15 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

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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
Yes
No
Yes
No CLOSE

Customer Contact

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