DEVICE: TruDenta M (00857869005222)

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Device Identifier (DI) Information

TruDenta M
M

Electromedical Products International, Inc.
00857869005222
GS1
1
Alpha-Stim M 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/physical-therapy electrical stimulation system A battery-powered, portable, electronic device designed to apply transcutaneous electrical stimulation to treat: 1) stress and stress-related disorders, including but not limited to anxiety, depression, and insomnia; and 2) neuromuscular symptoms (e.g., pain) and disorders typically as a form of physical therapy. It consists of a pulse generator (EPG) with separate channels for connection of a dedicated electrode/probe for each application. 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
June 30, 2015

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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
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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