MEDFIX INTERNATIONAL, LLC

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) (6) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (3) GAUGE, DEPTH (HTJ) (1)

Premarket Exempt

Yes

Clear

Medfix - 00810021830018 Catalog Number :

Device Description : Medfix® Color Coded Depth Gauge

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : No

Device Count : 1

Medfix - 00810021830025 Catalog Number :

Device Description : Medfix® Distractor Frame, 60mm Hinged Arms, 120mm Rack

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Medfix - 00810021830032 Catalog Number :

Device Description : Medfix® Quick-Release Retractor Handle

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Medfix - 00810021830049 Catalog Number :

Device Description : Medfix® Screw-On Retractor Handle

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Medfix - 00810021830056 Catalog Number :

Device Description : Medfix® Lumbar Retractor Frame, 240mm Rack

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830063 Catalog Number :

Device Description : Medfix® CS Double Hinged Longitudinal Scissor Grip Retractor

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830070 Catalog Number :

Device Description : Medfix® TL Transverse Retractor

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830087 Catalog Number :

Device Description : Medfix® TL Step-Down Retractor

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830094 Catalog Number :

Device Description : Medfix® Cervical Toeable Retractor, 120mm Rack, 60mm Arms

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830100 Catalog Number :

Device Description : Medfix® Midline Toeable Retractor, 160mm Rack, 60mm Arms

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

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