PC Mouse

GUDID 07290113781672

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290113781672
• NIH Device Record Key: 04305e99-1818-45d3-831c-13329e9e4e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PC Mouse
• Version Model Number: ACC00419
• Company DUNS: 600325755
• Company Name: AUGMEDICS LTD
• 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: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290113781672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250255

FDA Product Code

• SBF: Orthopedic Augmented Reality

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: 2026-02-13
• Device Publish Date: 2025-05-22

Devices Manufactured by AUGMEDICS LTD

• 07290113781672 - PC Mouse: 2026-02-13
• 07290113781672 - PC Mouse: 2026-02-13
• 17290113781730 - X2 Headset: 2026-02-13
• 07290113781702 - X2 Accessories Kit: 2026-02-13
• 07290113781719 - X2 Headset Battery LARGE: 2026-02-13
• 07290113781726 - X2 Headset Battery SMALL: 2026-02-13
• 07290113781115 - Patient Marker Extender: 2025-03-26
• 07290113781122 - C-arm Ring Adaptor: 2025-03-26
• 07290113781252 - XVS C Headset IPD-60 LCD Display: 2025-03-26