Definium

GUDID 00195278913807

Definium Pace Select ET System UDI

Hangwei GE Medical Systems Co., Ltd.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00195278913807
• NIH Device Record Key: 5d36ead6-cb89-4d7a-998b-b971142aa160
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Definium
• Version Model Number: Pace Select ET
• Company DUNS: 654659689
• Company Name: Hangwei GE Medical Systems Co., Ltd.
• 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: false
• 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	00195278913807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242678

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-07
• Device Publish Date: 2024-10-30

On-Brand Devices [Definium]

• 00195278118356: Definium Tempo System UDI
• 00195278070265: Definium Tempo Pro System UDI
• 00195278526892: Definium Pace Select system designated medical device
• 00195278913807: Definium Pace Select ET System UDI