DEVICE: Xavant Technology (06009880396023)

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Device Identifier (DI) Information

Xavant Technology
STIMPOD NMS415 KIT
XT-41501
XAVANT TECHNOLOGY (PTY) LTD
06009880396023
GS1
1
The STIMPOD NMS415 is a precision nerve mapping tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to the nerve mapping probe. The distance of the nerve mapping probe from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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

GMDN Preferred Term Name GMDN Definition
Diagnostic peripheral nerve electrical stimulation system An assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.
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FDA Product Code

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Product Code Product Code Name
BXN Stimulator, Nerve, Battery-Powered
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Sterilization

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

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Storage and Handling
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 26, 2016

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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
16009880396020 1 06009880396023 In Commercial Distribution Box
26009880396027 5 06009880396023 In Commercial Distribution Box
36009880396024 2 26009880396027 In Commercial Distribution Box
46009880396021 2 36009880396024 In Commercial Distribution Box
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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