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) (10)

Premarket Exempt

No Yes

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Dornier MedTech - 00810116020256 Catalog Number : HLFDF200C

Device Description : RFID Single Use 200 Series Flex (270 Micron) Ball Tip Laser Fiber

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020331 Catalog Number : HOL200SBT

Device Description : Dornier GentleFlex 200 Laser Fiber - Dornier Direct

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020348 Catalog Number : HOL200S

Device Description : Dornier SingleFlex 200 Laser Fiber - Dornier Direct

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020355 Catalog Number : HOL270S

Device Description : Dornier SingleFlex 270 Laser Fiber - Dornier Direct

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020362 Catalog Number : HOL400S

Device Description : Dornier SingleFlex 400 Laser Fiber - Dornier Direct

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020379 Catalog Number : HOL600S

Device Description : Dornier SingleFlex 600 Laser Fiber - Dornier Direct

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020386 Catalog Number : HOL1000S

Device Description : Dornier SingleFlex 1000 Laser Fiber - Dornier Direct

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020447 Catalog Number : HOL270R

Device Description : Dornier SmartFlex 270 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 - 00810116020454 Catalog Number : HOL400R

Device Description : Dornier SmartFlex 400 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 - 00810116020461 Catalog Number : HOL600R

Device Description : Dornier SmartFlex 600 Reusable Laser Fiber - Dornier Direct

Device Class :

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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