4 Channel Y-Adaptor Lead

GUDID 00817020020679

INTELLIGENT HEARING SYSTEMS CORP.

Analytical scalp lead

• Primary Device ID: 00817020020679
• NIH Device Record Key: 9cc4212c-8dd8-4617-987b-605a9705b81b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4 Channel Y-Adaptor Lead
• Version Model Number: M013901D
• 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	00817020020679 [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

Devices Manufactured by INTELLIGENT HEARING SYSTEMS CORP.

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• 00817020021058 - Bone Vibrator w/ Cable and Headband (B81): 2021-02-18
• 00817020021065 - DD45-300 Headphones: 2021-02-18
• 00817020020808 - SmartEP Software: 2019-07-12
• 00817020020815 - SmartEP-ASSR Software: 2019-07-12
• 00817020020822 - SmartScreener-Plus2 Screener Launch: 2019-07-12
• 00817020020839 - SmartScreener-Plus2 AEP Module: 2019-07-12
• 00817020020846 - SmartScreener-Plus2 OAE Module: 2019-07-12