TruDenta Electrodes

GUDID 00857869005215

TruDenta Electrodes

Electromedical Products International, Inc.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00857869005215
• NIH Device Record Key: cdc7593d-5ac7-42b3-af9b-4bf5fbb2d7ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruDenta Electrodes
• Version Model Number: TruDenta Electrodes
• Company DUNS: 610954729
• Company Name: Electromedical Products International, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857869005215 [Primary]
GS1	10857869005212 [Package]; Package: autobag [10 Units]; In Commercial Distribution
GS1	20857869005219 [Package]; Contains: 10857869005212; Package: case [30 Units]; In Commercial Distribution

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-06-30

Devices Manufactured by Electromedical Products International, Inc.

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• 00857869005260 - Alpha-Stim AID: 2020-03-05 Alpha-Stim AID kit - US
• 00857869005000 - Alpha-Stim M: 2019-05-23 Alpha-Stim M kit - China
• 00857869005185 - Alpha-Stim PPM: 2019-05-23 Alpha-Stim PPM kit
• 00857869005192 - Alpha-Stim 100: 2019-05-23 Alpha-Stim 100 kit