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) (4) System, Image Processing, Radiological (LLZ) (4) Plate, Bone (JEY) (3) Plate, Cranioplasty, Preformed, Non-Alterable (GXN) (3)

Premarket Exempt

Clear

AccuPlate - 00810007630564 Catalog Number : MC-PLT011

Device Description : MANDIBLE, 2.6 DOUBLE ANGLE

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

AccuPlate - 00810007630571 Catalog Number : MC-PLT012

Device Description : MANDIBLE, 2.6 FULL

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

AccuPlate - 00810007630588 Catalog Number : MC-K036

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

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

AccuShape® - 00810007630618 Catalog Number : ZB-SPK20

Device Description : PEEK Cranial Implant, Medium

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

AccuShape® - 00810007630625 Catalog Number : ZB-SPK30

Device Description : PEEK Cranial Implant, Large

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

AccuShape® - 00810007630632 Catalog Number : ZB-SPK40

Device Description : PEEK Cranial Implant, Extra Large

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630649 Catalog Number : ZB-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 - 00810007630656 Catalog Number : ZB-K000-R

Device Description : ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630663 Catalog Number : ZB-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 - 00810007630670 Catalog Number : ZB-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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