XVS MARKERS WITH C-LINK KIT 10 SETS PACK

GUDID 27290113781041

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 27290113781041
• NIH Device Record Key: ed604207-3458-49ac-b2c1-f1d664e1c5bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XVS MARKERS WITH C-LINK KIT 10 SETS PACK
• Version Model Number: ASP07059
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	17290113781044 [Primary]
GS1	27290113781041 [Package]; Contains: 17290113781044; Package: Shipping Box [10 Units]; Discontinued: 2024-10-24; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241481

FDA Product Code

• SBF: Orthopedic Augmented Reality

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-01
• Device Publish Date: 2024-10-24

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
• 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