GMR40 Retrofit Kit

GUDID 10815411020298

NEUROLOGICA CORP.

Computed radiography digital imaging scanner

• Primary Device ID: 10815411020298
• NIH Device Record Key: a67667f0-f646-4536-b262-5bf1eba26e2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMR40 Retrofit Kit
• Version Model Number: GMR40
• 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: true
• 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	10815411020298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171085

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-08-24

Devices Manufactured by NEUROLOGICA CORP.

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• 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