DORNIER MEDTECH AMERICA, INC.

Address:1155 ROBERTS BLVD.,KENNESAW,GA,30144,US

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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

Dislodger, Stone, Flexible (FGO) (2) System, X-Ray, Angiographic (IZI) (2) Drape, Surgical (KKX) (1) Powered Laser Surgical Instrument (GEX) (1) Ureteroscope And Accessories, Flexible/Rigid (FGB) (1)

Premarket Exempt

No Yes

Clear

Dornier MedTech - 00810116022588 Catalog Number : K2311580

Device Description : 600 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116022908 Catalog Number : BVEN11211

Device Description : Nitonol Stone Extractor, 1.5Fr x 120cm,11mm Open Tip

Device Class : 2

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : FGO

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022915 Catalog Number : BVEN2128

Device Description : Nitonol Stone Extractor, 2.0Fr x 120cm, 8mm Open Tip

Device Class : 2

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : FGO

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116023004 Catalog Number : AX93US31BR

Device Description : Disposable Flexible Ureterscope Reverse Deflection

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : FGB

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116023011 Catalog Number : FTSXCVRSM

Device Description : Nonsterile Equipment Small Cover for the X-Ray Footswitch 24” x 24”

Device Class : 2

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : IZI

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116023028 Catalog Number : FTSXCVRLG

Device Description : Nonsterile Equipment Large Cover for the Movement Footswitch 26” x 26”

Device Class : 2

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : IZI

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116023035 Catalog Number : 10501000

Device Description : Non- sterile flexible disposable drain bag with hose adapters for use on Dornier Non- sterile flexible disposable drain bag with hose adapters for use on Dornier Genesis Urological Table

Device Class : 2

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

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