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) (7) RETRACTOR (GAD) (2) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1)

Premarket Exempt

Yes

Clear

Medfix - 00810021830216 Catalog Number :

Device Description : Medfix® Vision Cervical Large I.D Tag

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830223 Catalog Number :

Device Description : Medfix® Vision Lumbar Large I.D Tag

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830230 Catalog Number :

Device Description : Medfix® Vision MIS Large I.D Tag

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830247 Catalog Number :

Device Description : Medfix® Vision Articulating Arm Large I.D Tag

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830254 Catalog Number :

Device Description : Medfix® Vision Instruments Large I.D Tag

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830261 Catalog Number :

Device Description : Medfix® Vision TRS Large I.D Tag

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830278 Catalog Number :

Device Description : Medfix® Vision Modular Spine System Large I.D Tag

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830285 Catalog Number :

Device Description : Medfix® McCulloch Hinged Retractor

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830292 Catalog Number :

Device Description : Medfix® McCulloch Rigid Retractor

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830308 Catalog Number :

Device Description : Medfix® Elliptical Lumbar Top Loading Blade Holder

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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