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) (10)

Premarket Exempt

Clear

MAXUM - M737M31001 Catalog Number :

Device Description : MAXUM IPC

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M31101 Catalog Number :

Device Description : MAXUM IPC REMAKE

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M31991 Catalog Number :

Device Description : MAXUM IPC FIT DEMO

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M410L1 Catalog Number :

Device Description : IMPLANT ASSEMBLY WITH IPC, LEFT

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M410R1 Catalog Number :

Device Description : IMPLANT ASSEMBLY WITH IPC, RIGHT

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M420L1 Catalog Number :

Device Description : IMPLANT ASSEMBLY WITH IPC, SPLIT COIL, LEFT

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M420R1 Catalog Number :

Device Description : IMPLANT ASSEMBLY WITH IPC, SPLIT COIL, RIGHT

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M51001 Catalog Number :

Device Description : MAXUM CLINICIAN'S SET

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M52001 Catalog Number :

Device Description : MAXUM IMPRESSION SET

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

MAXUM - M737M53001 Catalog Number :

Device Description : MAXUM CUSTOMIZATION SET

Device Class : 3

Duns Number: 833067478

Premarket Exempt : No

Product Code : MPV

Prescription Use : No

Device Count : 1

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