Ototronix, LLC

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

Cement, Ear, Nose And Throat (NEA) (4) Implant, Hearing, Active, Middle Ear, Partially Implanted (MPV) (4) Audiometer (EWO) (2)

Premarket Exempt

No

Clear

PROCEM - M7379860011 Catalog Number : 986-001

Device Description : Procem Cement - Grace Medical

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : NEA

Prescription Use : No

Device Count : 1

PROCEM - M7379860021 Catalog Number : 986-002

Device Description : Procem Applicator - Grace Medical

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : NEA

Prescription Use : No

Device Count : 1

PROCEM - M7379860031 Catalog Number : 986-003

Device Description : Procem Activator - Grace Medical

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : NEA

Prescription Use : No

Device Count : 1

PROCEM - M7379860041 Catalog Number : 986-004

Device Description : Procem Amalgamator - Grace Medical

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : NEA

Prescription Use : No

Device Count : 1

Otogram - M737G50001 Catalog Number :

Device Description : Otogram G5000

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Otogram - M737G55001 Catalog Number :

Device Description : Otogram G5500

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

MAXUM - M737M210L1 Catalog Number :

Device Description : IMPLANT ASSEMBLY, LEFT (IMPLANT ONLY)

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M210R1 Catalog Number :

Device Description : IMPLANT ASSEMBLY, RIGHT (IMPLANT ONLY)

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M220L1 Catalog Number :

Device Description : IMPLANT ASSEMBLY, SPLIT COIL, LEFT (IMPLANT ONLY)

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M220R1 Catalog Number :

Device Description : IMPLANT ASSEMBLY, SPLIT COIL, RIGHT (IMPLANT ONLY)

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

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