Standard xvision tray, instruments included

GUDID 07290113781658

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290113781658
• NIH Device Record Key: 51494e44-a993-47b6-95a2-33b562b8bb8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard xvision tray, instruments included
• Version Model Number: AMCH00051
• 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: 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	07290113781658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250255

FDA Product Code

• SBF: Orthopedic Augmented Reality

Sterilization

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

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

[07290113781658]

Moist Heat or Steam Sterilization

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

On-Brand Devices [Standard xvision tray, instruments included]

• 07290113781009: AMCH00040
• 07290113781658: AMCH00051