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, Cranioplasty, Preformed, Non-Alterable (GXN) (7) Driver, Wire, And Bone Drill, Manual (DZJ) (3) System, Image Processing, Radiological (LLZ) (3)

Premarket Exempt

Clear

AccuShape® - 00810007630106 Catalog Number : MC-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® - 00810007630113 Catalog Number : MC-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® - 00810007630120 Catalog Number : MC-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

AccuShape® - 00810007630137 Catalog Number : MC-SPK50

Device Description : PEEK Cranial Implant, XXL

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

AccuShape® - 00810007630168 Catalog Number : ACS-SM-E

Device Description : PEEK Cranial Implant, Small

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

AccuShape® - 00810007630175 Catalog Number : ACS-LG-E

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® - 00810007630182 Catalog Number : ZB-SPK10

Device Description : PEEK Cranial Implant, Small

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

AccuModel - 00810007630199 Catalog Number : MC-3D-M

Device Description : ANATOMICAL MODEL, MISCELLANEOUS

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel - 00810007630205 Catalog Number : MC-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 - 00810007630212 Catalog Number : MC-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

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