Revolution RevolutionAscendElite

GUDID 00195278718129

Ascend Elite Gantry common top asm with UDI

GE HEALTHCARE JAPAN CORPORATION

Full-body CT system

• Primary Device ID: 00195278718129
• NIH Device Record Key: c76ec879-f463-4b13-b1c9-c17b73d57028
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution
• Version Model Number: Ascend Elite
• Catalog Number: RevolutionAscendElite
• Company DUNS: 696021596
• Company Name: GE HEALTHCARE JAPAN CORPORATION
• 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	00195278718129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213938
• Premarket Notification: K233698

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-03
• Device Publish Date: 2024-04-25

On-Brand Devices [Revolution]

• 00840682109796: EVO
• 00840682146173: NGX Gantry common top asm with UDI
• 00195278718204: Ascend Select Gantry common top asm with UDI
• 00195278718136: Ascend Plus Gantry common top asm with UDI
• 00195278718129: Ascend Elite Gantry common top asm with UDI