MAXIFLEX, LLC

Address:512 Verret St,New Orleans,LA,70114,US

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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

Clear

MaxiFlex Holmium Laser Fiber - B324MF1000BH0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers.

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MaxiFlex Holmium Laser Fiber - B324MF1000BHC0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers.

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MaxiFlex Holmium Laser Fiber - B324MF1000BHCR0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers (reusable).

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MaxiFlex Holmium Laser Fiber - B324MF1000BHD0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers.

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MaxiFlex Holmium Laser Fiber - B324MF1000BHDR0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers (reusable).

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MaxiFlex Holmium Laser Fiber - B324MF1000BHN0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers.

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MaxiFlex Holmium Laser Fiber - B324MF1000BHNR0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers (reusable).

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MaxiFlex Holmium Laser Fiber - B324MF1000BHR0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers (reusable).

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MaxiFlex Holmium Laser Fiber - B324MF1000BHT0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers.

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MaxiFlex Holmium Laser Fiber - B324MF1000BHTR0 Catalog Number :

Device Description : 940 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers (reusable).

Device Class : 2

Duns Number: 198887072

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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