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

Powered Laser Surgical Instrument (GEX) (7) Dislodger, Stone, Flexible (FGO) (3)

Premarket Exempt

No Yes

Clear

Dornier MedTech - 00810116022359 Catalog Number : BVEN1128

Device Description : Nitonol Stone Extractor, 1.5Fr 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 - 00810116022366 Catalog Number : BVEN21211

Device Description : Nitonol Stone Extractor, 2.0Fr 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 - 00810116022373 Catalog Number : BCLU2120

Device Description : Dornier Clutch 2.0Fr, 120cm Tipless 3 Wire Stone Retrieval Basket

Device Class : 2

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : FGO

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022380 Catalog Number : K2308084

Device Description : 600 micron core/1040 micron OD Luer Lock 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 - 00810116022403 Catalog Number : K2310292

Device Description : 365 micron core/730 micron OD Luer Lock 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 - 00810116022427 Catalog Number : K2310710

Device Description : 400 micron core/730 micron OD Luer Lock 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 - 00810116022441 Catalog Number : K2312393

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

Device Class :

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116022526 Catalog Number : K2311822

Device Description : 400 micron core/730 micron OD Luer Lock Diode Laser Fiber, 2.5 meters

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116022540 Catalog Number : K2311824

Device Description : 600 micron core/1040 micron OD Luer Lock Diode Laser Fiber, 2.5 meters

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116022564 Catalog Number : K2311577

Device Description : 400 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters

Device Class :

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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