5-Electrode Lead Patient Cable

GUDID 00817020020112

INTELLIGENT HEARING SYSTEMS CORP.

Analytical scalp lead Analytical scalp lead Analytical scalp lead

• Primary Device ID: 00817020020112
• NIH Device Record Key: 919cc27d-7cbc-4c15-aa97-b0cb414d1ba2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5-Electrode Lead Patient Cable
• Version Model Number: M010332
• Company DUNS: 154870455
• Company Name: INTELLIGENT HEARING SYSTEMS CORP.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00817020020112 [Primary]

FDA Product Code

• IKD: Cable, Electrode

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: 2016-09-24

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