TN-28

GUDID B1870250

TENS device

NEUROTRON MEDICAL, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: B1870250
• NIH Device Record Key: 4798caee-ddff-4b83-a908-c34addbb7260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TN-28
• Version Model Number: TKT-5002
• Company DUNS: 147018519
• Company Name: NEUROTRON MEDICAL, 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1870250 [Primary]

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: 2016-09-23

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