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

Driver, Wire, And Bone Drill, Manual (DZJ) (9) System, Image Processing, Radiological (LLZ) (9) Plate, Bone (JEY) (1)

Premarket Exempt

Clear

AccuModel® - 00810007630786 Catalog Number : ZB-3D100

Device Description : ANATOMICAL MODEL, HOST BONE PERI-DEFECT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007630793 Catalog Number : ZB-3D101

Device Description : ANATOMICAL MODEL, IMPLANT MODEL

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007630809 Catalog Number : ZB-3D102

Device Description : ANATOMICAL MODEL, GRAFT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007630816 Catalog Number : ZB-3D202

Device Description : ANATOMICAL MODEL, MANDIBLE

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007630823 Catalog Number : ZB-3D203

Device Description : ANATOMICAL MODEL, MAXILLA

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007630830 Catalog Number : ZB-3D204

Device Description : ANATOMICAL MODEL, MANDIBLE AND MAXILLA

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007630847 Catalog Number : ZB-3D206

Device Description : ANATOMICAL MODEL, SKULL

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007630854 Catalog Number : ZB-3D207

Device Description : ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED)

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007630861 Catalog Number : ZB-3D108

Device Description : ANATOMICAL MODEL, FIBULA

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlate® Patient-Specific Plate - 00810007630878 Catalog Number : ZB-PLT001

Device Description : MANDIBLE, 2.0 STRAIGHT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

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