GUDID 00840682144209

GE MEDICAL SYSTEMS, INC.

PET system

• Primary Device ID: 00840682144209
• NIH Device Record Key: 73586b9a-0509-427a-8fb2-bdb66d5961ce
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5777746
• 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: 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	00840682144209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133657

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: 2
• Public Version Date: 2019-07-16
• Device Publish Date: 2018-12-21

Devices Manufactured by GE MEDICAL SYSTEMS, INC.

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• 00195278901439 - Omni: 2024-09-23 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY - WSO
• 00195278454218 - Omni: 2024-08-15 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY
• 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