Ototronix, LLC

Address:3727 Greenbriar Drive, Suite 203,Stafford,TX,77477,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

Implant, Hearing, Active, Middle Ear, Partially Implanted (MPV) (7) Cement, Ear, Nose And Throat (NEA) (2) Audiometer (EWO) (1)

Premarket Exempt

Clear

MAXUM - M737M70191 Catalog Number :

Device Description : HOOK, RIGHT ANGLE, RIGHT

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M70201 Catalog Number :

Device Description : HOOK, RIGHT ANGLE, LEFT

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M70301 Catalog Number :

Device Description : FORCEPS, STRAIGHT CYLINDER HOLDING

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M70311 Catalog Number :

Device Description : FORCEPS, ANGLED CYLINDER HOLDING

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M70331 Catalog Number :

Device Description : FORCEPS, STRAIGHT FLAT

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M70341 Catalog Number :

Device Description : DEVICE, 22G SUCTION LUER LOCK

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M70351 Catalog Number :

Device Description : DEVICE, 20G SUCTION LUER LOCK

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

Otogram - M737ML40001 Catalog Number :

Device Description : Otogram ML4000 (Otovest)

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

PROCEM - M737P97021 Catalog Number :

Device Description : Procem Cement

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : NEA

Prescription Use : No

Device Count : 1

PROCEM - M737P97201 Catalog Number :

Device Description : Procem Mixer

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : NEA

Prescription Use : No

Device Count : 1

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