Dornier Delta III K1045937

GUDID 04049957006464

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

Dornier MedTech Systems GmbH

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Primary Device ID04049957006464
NIH Device Record Keydd7972ec-6792-43b8-a7d0-0024291e2ebc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDornier Delta III
Version Model NumberK1045937
Catalog NumberK1045937
Company DUNS318165065
Company NameDornier MedTech Systems GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049957006464 [Primary]

FDA Product Code

LNSLithotriptor, Extracorporeal Shock-Wave, Urological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-03
Device Publish Date2023-03-24

On-Brand Devices [Dornier Delta III ]

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

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