Materialise NV

Address:15 TECHNOLOGIELAAN,LEUVEN Vlaams Brabant,BE

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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, Bone (JEY) (6) Neurological Stereotaxic Instrument (HAW) (2) Template (HWT) (2)

Premarket Exempt

No Yes

Clear

ProPlan CMF - 05420060350085 Catalog Number : SD900.008

Device Description : Patient Specific Instrument and Planning Kit, Orthognathic Kit, two Splints

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350092 Catalog Number : SD900.009

Device Description : Patient Specific Instrument and Planning Kit, Orthognathic Kit, one Splint

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350108 Catalog Number : SD900.010

Device Description : Patient Specific Instrument and Planning Kit, Cranial Vault Reconstruction with Model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350115 Catalog Number : SD900.011

Device Description : Patient Specific Instrument and Planning Kit, Cranial Vault Reconstruction, without Model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350511 Catalog Number : SD900.051

Device Description : Patient Specific Instrument and Planning Kit, Mandible Reconstruction, no model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350542 Catalog Number : SD900.054

Device Description : Patient Specific Instrument and Planning Kit, Midface Recon, no model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350566 Catalog Number : SD900.056

Device Description : Patient Specific Instrument and Planning Kit, Basic Midface Reconstruction

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350573 Catalog Number : SD900.008

Device Description : Splint and Planning Kit, Orthognathic Kit, two Splints

Device Class : 1

Duns Number: 373139427

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350580 Catalog Number : SD900.009

Device Description : Splint and Planning Kit, Orthognathic Kit, one Splint

Device Class : 1

Duns Number: 373139427

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060351013 Catalog Number : SD900.101

Device Description : Patient Specific Guide, Mandible

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

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