8” Tablet

GUDID 07290113780712

AUGMEDICS LTD

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

• Primary Device ID: 07290113780712
• NIH Device Record Key: 0f7f3e97-1232-4a23-95f8-8cfec89f0d5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8” Tablet
• Version Model Number: ACC00310
• 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	07290113780712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211188

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

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: 2021-08-13
• Device Publish Date: 2021-08-05

Devices Manufactured by AUGMEDICS LTD

• 07290113781061 - Augmedics WS-Cart assembly: 2024-03-26
• 07290113780996 - Swivel 3-4 mm universal tool adapter Leg up: 2023-09-18
• 07290113781009 - Standard xvision tray, instruments included: 2023-09-18
• 07290113781016 - Standard perc pin tray, instruments included: 2023-09-18
• 17290113780986 - XVS STERILE COMPONENTS KIT: 2021-09-13
• 07290113780712 - 8” Tablet: 2021-08-13
• 07290113780712 - 8” Tablet: 2021-08-13
• 07290113780729 - 8” Tablet Docking: 2021-08-13
• 07290113780859 - Perc Pin Tray: 2021-08-13