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

Clear

Dornier MedTech - 00810116020003 Catalog Number : HLFD0270C

Device Description : RFID Single Use 270 Micron Laser Fiber

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020010 Catalog Number : HLFD0400C

Device Description : RFID Single Use 400 Micron Laser Fiber

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020027 Catalog Number : HLFD0600C

Device Description : RFID Single Use 600 Micron Laser Fiber

Device Class :

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020034 Catalog Number : HLFD1000C

Device Description : RFID Single Use 1000 Micron Laser Fiber

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020041 Catalog Number : HLFR1000C

Device Description : RFID Reusable 1000 Micron Laser Fiber

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020058 Catalog Number : HLFR0600C

Device Description : RFID Reusable 600 Micron Laser Fiber

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020065 Catalog Number : HLFR0400C

Device Description : RFID Reusable 400 Micron Laser Fiber

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020072 Catalog Number : HLFR0270C

Device Description : RFID Reusable 270 Micron Laser Fiber

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020218 Catalog Number : HLFDS200C

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

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 00810116020249 Catalog Number : HLFRS200C

Device Description : RFID Reusable 200 Series (270 Micron) Laser Fiber

Device Class : 2

Duns Number: 130789944

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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