C-arm Ring Adaptor

GUDID 07290113781054

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290113781054
• NIH Device Record Key: 52c8ca49-e9c2-4462-a334-17c02e2a98c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-arm Ring Adaptor
• Version Model Number: AMCH07610
• 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	07290113781054 [Primary]

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: false

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 [C-arm Ring Adaptor]

• 07290113781054: AMCH07610
• 07290113781122: AMCH07619