DEVICE: TruDenta M (00857869005222)
Device Identifier (DI) Information
TruDenta M
M
In Commercial Distribution
Electromedical Products International, Inc.
M
In Commercial Distribution
Electromedical Products International, Inc.
Alpha-Stim M kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61168 | Psychiatric-therapy/physical-therapy transcutaneous 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6f06bc18-07d2-47ba-bffc-1241cf237068
May 23, 2019
3
June 30, 2015
May 23, 2019
3
June 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined