DEVICE: Alpha-Stim SCS (00857869005208)

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Device Identifier (DI) Information

Alpha-Stim SCS
SCS

Electromedical Products International, Inc.
00857869005208
GS1
1
Alpha-Stim SCS kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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No
Yes
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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
Psychiatric-therapy face/head electrical stimulation system A battery-powered device assembly designed to apply electrical stimuli for the treatment of stress and stress-related disorders, including but not limited to anxiety, depression, and insomnia. It consists of an external pulse generator (EPG), and electrodes for placement on the skin surface (e.g., the area below the ear or ear lobe). The device may be used in the home or in a clinical setting.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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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 Status

In Commercial Distribution
October 28, 2014

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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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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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