XVS MARKERS FOR ASC KIT 3 SETS PACK

GUDID 27290113781034

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 27290113781034
• NIH Device Record Key: 75f48485-5f99-45d6-a8a9-366602d394fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XVS MARKERS FOR ASC KIT 3 SETS PACK
• Version Model Number: ASP07056
• 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: true
• 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	17290113781037 [Primary]
GS1	27290113781034 [Package]; Contains: 17290113781037; Package: Shipping Box [3 Units]; Discontinued: 2024-10-24; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241481

FDA Product Code

• SBF: Orthopedic Augmented Reality

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: 2024-11-01
• Device Publish Date: 2024-10-24

On-Brand Devices [XVS MARKERS FOR ASC KIT 3 SETS PACK]

• 27290113781034: ASP07056
• 27290113781164: ASP07073