X2 Headset Battery SMALL

GUDID 07290113781726

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290113781726
• NIH Device Record Key: 26102972-7685-4386-a575-63e985e707b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X2 Headset Battery SMALL
• Version Model Number: ABAT00004
• 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: 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	07290113781726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251639

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: 2025-11-19

Devices Manufactured by AUGMEDICS LTD

• 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
• 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