MAR

GUDID 00840682134989

GE MEDICAL SYSTEMS, INC.

CT system application software

• Primary Device ID: 00840682134989
• NIH Device Record Key: 6498c879-1aeb-44b0-8b30-116912ef7b52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAR
• Version Model Number: 1.0
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, INC.
• 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: true
• Serial Number: false
• 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	00840682134989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132410

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-25

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• 00195278840226 - Discovery: 2024-07-12 XR656HD UDI Label
• 00195278840233 - Optima: 2024-07-12 XR646HD UDI Label
• 00195278792822 - Omni: 2024-04-19 OMNI GANTRY ELECTRONICS ASSY, MEA