OPTION, NL4X00 WS-120V-S

GUDID 10815411020823

NEUROLOGICA CORP.

CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation CT system workstation

• Primary Device ID: 10815411020823
• NIH Device Record Key: 00ee51fe-2d2e-4a43-98e7-41853136e954
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTION, NL4X00 WS-120V-S
• Version Model Number: 0-00132-001
• 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	10815411020823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170238

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: 2023-08-23
• Device Publish Date: 2023-08-15

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
• 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