Ocutech A8000

GUDID 00850008829772

Battery-operated ultrasonic sensor attached to eyeglasses that warns the wearer of an obstacle they may collide with in the non-seeing visual field.

Ocutech, Inc.

Assistive echolocation device

• Primary Device ID: 00850008829772
• NIH Device Record Key: d79196e9-bfa7-4ed4-b9fb-504b963d6fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocutech
• Version Model Number: SideSight
• Catalog Number: A8000
• Company DUNS: 145767323
• Company Name: Ocutech, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008829772 [Primary]

FDA Product Code

• HPG: Aid, Vision, Electronic, Battery-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-20
• Device Publish Date: 2024-02-12