XVS C L-Headset IPD-60 Clear Display

GUDID 17290113781402

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 17290113781402
• NIH Device Record Key: 63c49408-d073-4965-8077-6ccdaf064bb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XVS C L-Headset IPD-60 Clear Display
• Version Model Number: AHMD602CLT
• 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	07290113781399 [Primary]
GS1	17290113781402 [Package]; Contains: 07290113781399; Package: Shipping box [1 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-26
• Device Publish Date: 2025-03-18

Devices Manufactured by AUGMEDICS LTD

• 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
• 17290113781280 - XVS C Headset IPD-64 LCD Display: 2025-03-26
• 17290113781303 - XVS C Headset IPD-68 LCD Display: 2025-03-26
• 17290113781327 - XVS C Headset IPD-60 Clear Display: 2025-03-26
• 17290113781341 - XVS C Headset IPD-64 Clear Display: 2025-03-26
• 17290113781365 - XVS C Headset IPD-68 Clear Display: 2025-03-26