Dornier MedTech K1039061

GUDID 04049957005634

Delta III Lithotripter, 7.5 KW

Dornier MedTech Systems GmbH

Electromechanical lithotripsy system, extracorporeal

• Primary Device ID: 04049957005634
• NIH Device Record Key: 569548aa-a8b6-44d7-9b5e-7fd6d1e64155
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier MedTech
• Version Model Number: Delta III
• Catalog Number: K1039061
• 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	04049957005634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172084

FDA Product Code

• LNS: Lithotriptor, Extracorporeal Shock-Wave,Urological

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]

• 04049957005634: Delta III Lithotripter, 7.5 KW
• 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