ddR Element

GUDID 00860011334613

Stationary Xray System

Swissray Medical AG

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00860011334613
• NIH Device Record Key: af96aa56-40e1-4b67-8b4c-5910ec3212e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ddR Element
• Version Model Number: ddR Element
• Company DUNS: 482051190
• Company Name: Swissray Medical AG
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011334613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110828

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2024-04-24
• Device Publish Date: 2024-04-16

Devices Manufactured by Swissray Medical AG

• 00860011334606 - ddR Cruze: 2024-04-24 Digital Mobile Diagnostic Xray System
• 00860011334613 - ddR Element: 2024-04-24Stationary Xray System
• 00860011334613 - ddR Element: 2024-04-24 Stationary Xray System
• 00860011334620 - ddR Formula Plus: 2024-04-24 Stationary Xray System