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

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (10) Shoulder Arthroplasty Implantation System (QHE) (5) Shoulder Prosthesis, Reverse Configuration (PHX) (5)

Premarket Exempt

No Yes

Clear

Lima PSI - E314SHCLM0101010 Catalog Number : SHC-LM01-01-01

Device Description : Lima CT RSA guide

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS, QHE, PHX

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM010201 Catalog Number : SHC-LM01-02-01

Device Description : Lima CT RSA bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM0102010 Catalog Number : SHC-LM01-02-01

Device Description : Lima CT RSA bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS, QHE, PHX

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM020001 Catalog Number : SHC-LM02-00-01

Device Description : Lima CT TSA guide and bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM0200010 Catalog Number : SHC-LM02-00-01

Device Description : Lima CT TSA guide and bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS, QHE, PHX

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM020101 Catalog Number : SHC-LM02-01-01

Device Description : Lima CT TSA guide

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM0201010 Catalog Number : SHC-LM02-01-01

Device Description : Lima CT TSA guide

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS, QHE, PHX

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM020201 Catalog Number : SHC-LM02-02-01

Device Description : Lima CT TSA bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM0202010 Catalog Number : SHC-LM02-02-01

Device Description : Lima CT TSA bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS, QHE, PHX

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM100001 Catalog Number : SHC-LM10-00-01

Device Description : Lima CT Full scapula bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

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