ddR Formula Plus

GUDID 00860011334620

Stationary Xray System

Swissray Medical AG

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• Primary Device ID: 00860011334620
• NIH Device Record Key: f7f25c20-779c-42aa-b116-6c019e58e603
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ddR Formula Plus
• Version Model Number: ddR Formula Plus
• 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	00860011334620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052943

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: 2024-04-24 Stationary Xray System
• 00860011334620 - ddR Formula Plus: 2024-04-24Stationary Xray System
• 00860011334620 - ddR Formula Plus: 2024-04-24 Stationary Xray System