Definium

GUDID 00840682104364

GE MEDICAL SYSTEMS, INC.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00840682104364
• NIH Device Record Key: d65cd29a-93ad-426e-8747-f894d4729bed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Definium
• Version Model Number: 5000
• 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

Customer Support Contacts

• Phone: +1(262)544-3011
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682104364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063283

FDA Product Code

• KPR: System, x-ray, stationary

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: 2016-08-01

Devices Manufactured by GE MEDICAL SYSTEMS, INC.

• 00195278560384 - Auto Segmentation: 2024-11-13 MD Auto Segmentation for Smart Subscription
• 00195278865335 - SnapShot Freeze 2: 2024-10-21 SnapShot Freeze Medical Device
• 00195278804990 - Revolution: 2024-09-23 Revolution UPG3 - Designated System Medical Device
• 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