BioStim Pre Wired Butterfly Electrodes EBTF400600MW

GUDID 00850706007175

Pack of three ea EBTF400600 containing two 4" x 6" electrodes. TOTAL 6.

BIOMEDICAL LIFE SYSTEMS, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00850706007175
• NIH Device Record Key: aeea8b0b-9060-493e-943d-16000ecc734e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioStim Pre Wired Butterfly Electrodes
• Version Model Number: EBTF400600MW
• Catalog Number: EBTF400600MW
• Company DUNS: 116956807
• Company Name: BIOMEDICAL LIFE SYSTEMS, 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: true
• Serial Number: false
• 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
GS1	00850706007175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160138

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2019-06-28
• Device Publish Date: 2018-05-22

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