DEVICE: MobiTrakVNG Receiver (B292M9174150)

Device Identifier (DI) Information

MobiTrakVNG Receiver
M917415
In Commercial Distribution

MEDTRAK VNG, INC.
B292M9174150
HIBCC

1
968641824 *Terms of Use
No description.
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Device Characteristics

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

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
Eye movement analysis system An assembly of mains electricity (AC-powered) devices designed to measure, evaluate and record the movement of the eyes. The device is intended to measure ocular dynamics, typically measuring both horizontal and vertical eye movements. This device can include a stimulus source (e.g., a light bar), a sensing device (e.g., video or infrared cameras), a computer, and a recorder. Some systems may include cameras and/or eyelid trackers mounted on spectacles or headbands.
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FDA Product Code

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Product Code Product Code Name
GWN Nystagmograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K925111 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4060bbc9-d595-4e0a-946f-02fbdab333bd
July 06, 2018
3
September 22, 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
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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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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