OAE 10D Probe

GUDID 00817020020273

INTELLIGENT HEARING SYSTEMS CORP.

Otoacoustic emission system, line-powered

• Primary Device ID: 00817020020273
• NIH Device Record Key: 26d65735-e7e9-4aa8-9fc1-d0b557bb1e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OAE 10D Probe
• Version Model Number: M032103
• 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	00817020020273 [Primary]

FDA Product Code

• EWO: Audiometer

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

On-Brand Devices [OAE 10D Probe]

• 00817020029993: OAE 10D Probe with calibration thumbdrive
• 00817020020273: M032103