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) (3) Stylet, Ureteral (EYA) (3) Powered Laser Surgical Instrument (GEX) (2) Ureteroscope And Accessories, Flexible/Rigid (FGB) (2)

Premarket Exempt

No Yes

Clear

Dornier MedTech - 00810116020478 Catalog Number : HOL1000R

Device Description : Dornier SmartFlex 1000 Reusable Laser Fiber - Dornier Direct

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020485 Catalog Number : HOL200R

Device Description : Dornier SmartFlex 200 Reusable Laser Fiber - Dornier Direct

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020553 Catalog Number : 48012512

Device Description : PTFE Coated Stainless Steel Guidewire, 0.035" diameter, 150 cm length, 3 cm tip.

Device Class :

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020560 Catalog Number : 48012513

Device Description : Combi Nitinol Guidewire, 0.038" diameter, 150 cm length, 3 cm tip.

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020577 Catalog Number : 48012515

Device Description : Tipless Basket, 1.5 Fr diameter, 120 cm length.

Device Class : 2

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : FGO

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020584 Catalog Number : 48012516

Device Description : Tipless Basket, 1.8 Fr diameter, 120 cm length.

Device Class : 2

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : FGO

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020591 Catalog Number : 48012517

Device Description : Helical Basket, 2.5 Fr diameter, 120 cm length.

Device Class : 2

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : FGO

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020676 Catalog Number : 48012514

Device Description : Hydrophilic Nitinol Guidewire, 0.035" diameter, 150 cm length, 3 cm tip.

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020690 Catalog Number : AX93US31B

Device Description : Single Use Digital Flexible Ureteroscope, Max. Insertion Portion Width: 3.1 mm, Single Use Digital Flexible Ureteroscope, Max. Insertion Portion Width: 3.1 mm, Max Insertion Channel Width: 1.2 mm, Bending Angle: -275° - +275°, Working Length: 650 mm

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : FGB

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020713 Catalog Number : AXPEOSB

Device Description : Digital Video Processor, Input Voltage: 5V 2A (for use with Dornier Ureteroscope)

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : FGB

Prescription Use : Yes

Device Count : 1

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