Electrical Stimulation Box

GUDID 00817020020297

INTELLIGENT HEARING SYSTEMS CORP.

Somatosensory electrical stimulation system

• Primary Device ID: 00817020020297
• NIH Device Record Key: 10be2bb1-f822-41c6-9d0b-937fc9e520e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrical Stimulation Box
• Version Model Number: M014910
• Company DUNS: 154870455
• Company Name: INTELLIGENT HEARING SYSTEMS CORP.
• 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: 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	00817020020297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070608

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

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: 2018-07-06
• Device Publish Date: 2016-09-24

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