CT SCANNER, NL5000

GUDID 10815411020335

NEUROLOGICA CORP.

Limited-view-field CT system

• Primary Device ID: 10815411020335
• NIH Device Record Key: 6f2c0f55-58f6-425b-aa94-ffd73cfdfae2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT SCANNER, NL5000
• Version Model Number: 0-NL5000-001
• 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	10815411020335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171183

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: 2019-11-04
• Device Publish Date: 2019-10-25

Devices Manufactured by NEUROLOGICA CORP.

• 10815411020014 - OPTION, HILL-ROM TOTALCARE ADAPTER: 2025-03-18
• 10815411020021 - Transfer Board Assembly: 2025-03-18
• 10815411020045 - OPTION, OR TABLE ADAPTER: 2025-03-18
• 10815411020090 - OPTION ASSY, STRYKER IN TOUCH CRITICAL CARE BED ADAPTER: 2025-03-18
• 10815411020113 - Universal Scan Board: 2025-03-18
• 10815411020120 - OPTION, STRYKER POWER PRO AMBULANCE BED ADAPTER: 2025-03-18
• 10815411020137 - OPTION ASSY, HILL ROM PROGRESSA PULMONARY BED ADAPTER: 2025-03-18
• 10815411020144 - ASSY, SCAN BOARD, HILL-ROM PROGRESSA: 2025-03-18