XVS STERILE COMPONENTS KIT

GUDID 17290113780108

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 17290113780108
• NIH Device Record Key: 4eda0a05-9537-4322-8023-3980a26c32c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XVS STERILE COMPONENTS KIT
• Version Model Number: ASP00014
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07290113780101 [Primary]
GS1	17290113780108 [Package]; Contains: 07290113780101; Package: Pouch [1 Units]; In Commercial Distribution
GS1	27290113780105 [Package]; Package: 10 Pack Set [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190929

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

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

On-Brand Devices [XVS STERILE COMPONENTS KIT]

• 17290113780108: ASP00014
• 17290113780986: ASP00051