OmniTom Elite

GUDID 10815411020663

NEUROLOGICA CORP.

Limited-view-field CT system

• Primary Device ID: 10815411020663
• NIH Device Record Key: 0d4b67c3-fc78-40e4-90f3-580f1cdf5237
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniTom Elite
• Version Model Number: 0-NL5000-002
• Company DUNS: 145008178
• Company Name: NEUROLOGICA CORP.
• 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	10815411020663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202526

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-18
• Device Publish Date: 2021-11-10

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