Amplio™ Digital Visualization System Kit

GUDID 00860011130727

Visulaization Headset, Syspack, Wired Controller, Headset Cable, and Belt

Unify Medical Inc.

General-purpose surgical microscope

• Primary Device ID: 00860011130727
• NIH Device Record Key: fd252dbc-0d58-4bcd-b9a1-1380f21ef870
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amplio™ Digital Visualization System Kit
• Version Model Number: AMP-001
• Company DUNS: 117471657
• Company Name: Unify Medical Inc.
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011130727 [Primary]

FDA Product Code

• FSO: MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY

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: 2023-12-27
• Device Publish Date: 2023-12-19

Devices Manufactured by Unify Medical Inc.

• 00860011130703 - Amplio™ Digital Visualization System: 2023-12-27 Syspack, Wired Controller, Headset Cable, and Belt
• 00860011130710 - Amplio™ Digital Visualization Headset: 2023-12-27 Visualization Headset
• 00860011130727 - Amplio™ Digital Visualization System Kit: 2023-12-27Visulaization Headset, Syspack, Wired Controller, Headset Cable, and Belt
• 00860011130727 - Amplio™ Digital Visualization System Kit: 2023-12-27 Visulaization Headset, Syspack, Wired Controller, Headset Cable, and Belt