MEDFIX INTERNATIONAL, LLC

Address:5620 North Kolb Road,Tucson,AZ,85750,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

TRAY, SURGICAL, INSTRUMENT (FSM) (4) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (3) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1) RETRACTOR (GAD) (1)

Premarket Exempt

Yes

Clear

Medfix - 00810021839912 Catalog Number :

Device Description : Medfix® Ti TRS Tubular Retractor Set Large Insert

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021839929 Catalog Number :

Device Description : Medfix® Vision CS Cervical Retractor Set Insert

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021839936 Catalog Number :

Device Description : Medfix® Vision Universal 1 Level Large Case

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021839943 Catalog Number :

Device Description : Medfix® Case With Lid, 22" x 10" x 2"

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021839950 Catalog Number :

Device Description : Medfix® Vision ALIF Ring Retractor Frame

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021839967 Catalog Number :

Device Description : Medfix® Vision ALIF Blade Holder

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Medfix - 00810021839974 Catalog Number :

Device Description : Medfix® Vision ALIF Ring Clamp

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Medfix - 00810021839981 Catalog Number :

Device Description : Medfix® Vision ALIF Ring Clamp for Blade Holder

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Medfix - 00810021839998 Catalog Number :

Device Description : Medfix® Vision ALIF Hex Driver Tool

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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