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) (10) System, Image Processing, Radiological (LLZ) (10)

Premarket Exempt

Clear

AccuModel - 00810007630229 Catalog Number : MC-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

AccuModel - 00810007630236 Catalog Number : MC-3D109

Device Description : ANATOMICAL MODEL, GUIDE

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel - 00810007630243 Catalog Number : MC-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 - 00810007630250 Catalog Number : MC-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 - 00810007630267 Catalog Number : MC-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 - 00810007630274 Catalog Number : MC-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 - 00810007630281 Catalog Number : MC-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

AccuPlan System - 00810007630298 Catalog Number : MC-K000

Device Description : ORTHOGNATHIC, SURGICAL PLANNING KIT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan System - 00810007630304 Catalog Number : MC-K001

Device Description : ORTHOGNATHIC, INTERMEDIATE SPLINT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan System - 00810007630311 Catalog Number : MC-K002

Device Description : ORTHOGNATHIC, FINAL SPLINT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

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