CT SCANNER , NL3000 ELITE, RAIL/PLATE CONFIG

GUDID 10815411020342

NEUROLOGICA CORP.

Limited-view-field CT system

• Primary Device ID: 10815411020342
• NIH Device Record Key: c1db0cfe-47bf-4cbe-b90a-e1d754266a3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT SCANNER , NL3000 ELITE, RAIL/PLATE CONFIG
• Version Model Number: 0-NL3000-005
• 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	10815411020342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172539

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.

• 10815411020809 - OPTION, NL4X00 WS-240V-S: 2023-08-23
• 10815411020816 - OPTION, NL4X00 WS-240V: 2023-08-23
• 10815411020823 - OPTION, NL4X00 WS-120V-S: 2023-08-23
• 10815411020755 - Water Phantom, 25 cm: 2023-06-23
• 10815411020533 - BodyTom 64: 2023-06-19
• 10815411020779 - TABLE NL5000 FULL BODY PEDIATRIC (FBPT): 2023-04-14
• 10815411020687 - CereTom Elite: 2022-02-23
• 10815411020595 - MSU STRETCHER: 2022-02-17