TruDenta M

GUDID 00857869005222

Alpha-Stim M kit

Electromedical Products International, Inc.

Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation system

• Primary Device ID: 00857869005222
• NIH Device Record Key: 6f06bc18-07d2-47ba-bffc-1241cf237068
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruDenta M
• Version Model Number: M
• Company DUNS: 610954729
• Company Name: Electromedical Products International, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00857869005222 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-23
• Device Publish Date: 2015-06-30

Devices Manufactured by Electromedical Products International, Inc.

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• 00857869005208 - Alpha-Stim SCS: 2020-03-05 Alpha-Stim SCS kit
• 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