Medcad

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) (10)

Premarket Exempt

No

Clear

AccuShape® - 00810007630007 Catalog Number : ACS-001

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® - 00810007630014 Catalog Number : ACS-002

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® - 00810007630021 Catalog Number : ACS-003

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® - 00810007630038 Catalog Number : ACS-004

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® - 00810007630045 Catalog Number : ACSS-001

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® - 00810007630052 Catalog Number : ACSM-002

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® - 00810007630069 Catalog Number : ACSL-003

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® - 00810007630076 Catalog Number : ACSX-004

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® - 00810007630083 Catalog Number : MC-SPK00

Device Description : PEEK Cranial Implant, Extra Small

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

AccuShape® - 00810007630090 Catalog Number : MC-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

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