Dornier MedTech K1034310

GUDID 04049957004231

Genesis Urology Imaging System, Left, FPD, 65 KW, 480 V

Dornier MedTech Systems GmbH

Stationary uro-gynaecological fluoroscopic x-ray system, digital

• Primary Device ID: 04049957004231
• NIH Device Record Key: 5cfac511-abd4-4e55-bba6-cd65269334ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier MedTech
• Version Model Number: Genesis
• Catalog Number: K1034310
• Company DUNS: 318165065
• Company Name: Dornier MedTech Systems GmbH
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049957004231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122768

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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: 2018-10-15
• Device Publish Date: 2018-09-13

On-Brand Devices [Dornier MedTech]

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• 04049957005566: Genesis Urology Imaging System, Left, UV, FPD, 80 KW, 480 V
• 04049957005559: Genesis Urology Imaging System, Right, UV, FPD, 80 KW, 480 V
• 04049957005429: Delta III Lithotripter, 15 KW
• 04049957004231: Genesis Urology Imaging System, Left, FPD, 65 KW, 480 V
• 04049957004224: Genesis Urology Imaging System, Left, FPD, 80 KW, 480 V
• 04049957004118: Genesis Urology Imaging System, Right, FPD, 80 KW, 480 V
• 04049957004095: Genesis Urology Imaging System, Right, FPD, 65 KW, 480 V
• 04049957003265: Gemini Lithotripter, 65 KW
• 04049957003135: Gemini Lithotripter, 50 KW
• 04049957000714: Relax+ Mobile Examination Table
• 04049957000578: UIMS Viewing Station SC High Line
• 04049957000561: UIMS Viewing Station SC Low Line
• 04049957000554: UIMS Viewing Station
• 04049957000028: Compact Sigma Lithotripter, 220V, 60 Hz
• 04049957000011: R- Compact Sigma Lithotripter, 120V, 60 Hz