Medcad

Address:3401 Technology Dr,Plano,TX,75074,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

Plate, Bone (JEY) (2) Driver, Wire, And Bone Drill, Manual (DZJ) (1) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

AccuPlate - 00810007631080 Catalog Number : ZB-K035

Device Description : MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT BUNDLED W/ ACCUPLATE

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

AccuPlate - 00810007631097 Catalog Number : ZB-K036

Device Description : MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT BUNDLED W/ ACCUPLATE, NO GUIDES

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007631103 Catalog Number : ZB-3D208

Device Description : ANATOMICAL MODEL, RIB, SINGLE

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

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