DEVICE: Accessory Box AB05 (04260223141751)

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Device Identifier (DI) Information

Accessory Box AB05
100676

PATH medical GmbH
04260223141751
GS1
1
Accessory box Sentiero Screening Content: 1. Transparent Lurex Box 11 compartments. AN100336 2. Ear tip ET-03 5 mm. AN100063 3. Ear tip Lamella 6-10mm, blue AN100064 4. Ear Tip, Lamella 8-11mm. AN100144 5. Ear tip ET-11 Lamella 12-16mm. AN100125 6. Probe Tip 'Adult' for Children & Adults. AN100013 7. EarTip Soft ET-16 10mm. AN100838 8. Ear tip Soft ET-17 14 mm. AN100839 9. Ear tip Soft ET-14 18mm. AN100230 10. Test cavity for EP-DP and EP-TE with Ear Probe Tip A. AN100129 11. Cleaning tool. AN100151
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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
Evoked-potential audiometer An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.
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FDA Product Code

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Product Code Product Code Name
GWJ Stimulator, Auditory, Evoked Response
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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
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Clinically Relevant Size

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Size Type Text
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Device Status

In Commercial Distribution
August 31, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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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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