Fixed 3-4mm Universal tool Adapter Leg Up

GUDID 07290113780071

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290113780071
• NIH Device Record Key: 6370a996-4c0e-40e4-b6fa-e16cf80d772f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixed 3-4mm Universal tool Adapter Leg Up
• Version Model Number: AMCFSU03
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290113780071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190929

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

[07290113780071]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-24
• Device Publish Date: 2020-03-16

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• 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