Dornier MedTech K1039062

GUDID 04049957005429

Delta III Lithotripter, 15 KW

Dornier MedTech Systems GmbH

Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal Electromechanical lithotripsy system, extracorporeal

• Primary Device ID: 04049957005429
• NIH Device Record Key: 534ab9dd-08a3-4cee-b7f8-28c9de8b97e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier MedTech
• Version Model Number: Delta III
• Catalog Number: K1039062
• 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	04049957005429 [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

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