Standard xvision tray, instruments included

GUDID 07290113781009

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290113781009
• NIH Device Record Key: 920acbbd-0eda-4012-a51c-74e5b8b62023
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard xvision tray, instruments included
• Version Model Number: AMCH00040
• 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	07290113781009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220905

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

[07290113781009]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2022-12-13

Devices Manufactured by AUGMEDICS LTD

• 07290113781054 - C-arm Ring Adaptor: 2024-11-01
• 07290113781078 - BNC to BNC Cable: 2024-11-01
• 07290113781085 - DVI-I to BNC Adaptor: 2024-11-01
• 07290113781092 - VGA to HDMI adaptor: 2024-11-01
• 07290113781108 - HDMI to HDMI cable: 2024-11-01
• 27290113781034 - XVS MARKERS FOR ASC KIT 3 SETS PACK: 2024-11-01
• 27290113781041 - XVS MARKERS WITH C-LINK KIT 10 SETS PACK: 2024-11-01
• 07290113781061 - Augmedics WS-Cart assembly: 2024-03-26