MiniCATIQ

GUDID 00860290000315

XORAN TECHNOLOGIES LLC

Cone beam computed tomography system, head/neck

• Primary Device ID: 00860290000315
• NIH Device Record Key: a736e101-0e82-4267-85a8-022e7eedae73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniCATIQ
• Version Model Number: 10009
• Company DUNS: 079255809
• Company Name: XORAN TECHNOLOGIES LLC
• 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	00860290000315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113421

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [MiniCATIQ]

• 00860290000315: 10009
• 00860008443731: 10015