Dornier MedTech Systems GmbH

Address:ARGELSRIEDER FELD 7,WESSLING Bavaria,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Lithotriptor, Extracorporeal Shock-Wave,Urological (LNS) (4) Software, Transmission And Storage, Patient Data (NSX) (3) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (2) Table, Cystometric, Non-Electric And Accessories (KQS) (1)

Premarket Exempt

Clear

Dornier MedTech - 04049957000011 Catalog Number : K1025660

Device Description : R- Compact Sigma Lithotripter, 120V, 60 Hz

Device Class : 2

Duns Number: 318165065

Premarket Exempt : No

Product Code : LNS

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049957000028 Catalog Number : K1029396

Device Description : Compact Sigma Lithotripter, 220V, 60 Hz

Device Class : 2

Duns Number: 318165065

Premarket Exempt : No

Product Code : LNS

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049957000554 Catalog Number : K1028986

Device Description : UIMS Viewing Station

Device Class : U

Duns Number: 318165065

Premarket Exempt : No

Product Code : NSX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049957000561 Catalog Number : K1029225

Device Description : UIMS Viewing Station SC Low Line

Device Class : U

Duns Number: 318165065

Premarket Exempt : No

Product Code : NSX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049957000578 Catalog Number : K1029226

Device Description : UIMS Viewing Station SC High Line

Device Class : U

Duns Number: 318165065

Premarket Exempt : No

Product Code : NSX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049957000714 Catalog Number : K1018869

Device Description : Relax+ Mobile Examination Table

Device Class : 1

Duns Number: 318165065

Premarket Exempt : No

Product Code : KQS

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049957003135 Catalog Number : K1032806

Device Description : Gemini Lithotripter, 50 KW

Device Class : 2

Duns Number: 318165065

Premarket Exempt : No

Product Code : LNS

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049957003265 Catalog Number : K1032810

Device Description : Gemini Lithotripter, 65 KW

Device Class : 2

Duns Number: 318165065

Premarket Exempt : No

Product Code : LNS

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049957004095 Catalog Number : K1034267

Device Description : Genesis Urology Imaging System, Right, FPD, 65 KW, 480 V

Device Class : 2

Duns Number: 318165065

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049957004118 Catalog Number : K1034269

Device Description : Genesis Urology Imaging System, Right, FPD, 80 KW, 480 V

Device Class : 2

Duns Number: 318165065

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

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