Dornier Delta III K1045937

GUDID 04049957006464

Dornier Delta III Pro - DELTA III PRO XRAY 7.5KW/SW E180 DMT-A

Dornier MedTech Systems GmbH

Electromechanical lithotripsy system, extracorporeal

• Primary Device ID: 04049957006464
• NIH Device Record Key: dd7972ec-6792-43b8-a7d0-0024291e2ebc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier Delta III
• Version Model Number: K1045937
• Catalog Number: K1045937
• 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	04049957006464 [Primary]

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: 2023-04-03
• Device Publish Date: 2023-03-24

On-Brand Devices [Dornier Delta III ]

• 04049957006471: Dornier Delta III Pro - DELTA III PRO XRAY 15KW/SW E180 DMT-A
• 04049957006464: Dornier Delta III Pro - DELTA III PRO XRAY 7.5KW/SW E180 DMT-A