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

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

Premarket Exempt

Yes

Clear

Medfix - 00810021830414 Catalog Number :

Device Description : Medfix® Weitlaner Retractor, Sharp Prongs, 3x4, 5 1/2" (14.0 cm)

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830421 Catalog Number :

Device Description : Medfix® Weitlaner Retractor, Blunt Prongs, 3x4, 5 1/2" (14.0 cm)

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830438 Catalog Number :

Device Description : Medfix® Dilator #1, 8mm, Silver

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830445 Catalog Number :

Device Description : Medfix® Dilator #1, 5.3mm, Ti

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830452 Catalog Number :

Device Description : Medfix® Rhoton Knife Handle, 5-1/8" WL, Total Length 9 1/2"

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Medfix - 00810021830469 Catalog Number :

Device Description : Medfix® Rhoton Knife Handle, 5-1/8" WL, Total Length 9 1/2", Black Coated

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Medfix - 00810021830476 Catalog Number :

Device Description : Medfix® Cushing Thumb Forceps, Tungsten Carbide, Serrated Tips, Scraper End, Bay Medfix® Cushing Thumb Forceps, Tungsten Carbide, Serrated Tips, Scraper End, Bayonet, 7 3/4" (19.7 cm)

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Medfix - 00810021830483 Catalog Number :

Device Description : Medfix® Universal Storage Insert

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830490 Catalog Number :

Device Description : Medfix® Vision Universal Distractor Insert

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830506 Catalog Number :

Device Description : Medfix® Lumbar Instruments Insert

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

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