DSM BIOMEDICAL, INC.

Address:735 Pennsylvania Dr,EXTON,PA,19341,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

Barrier, Animal Source, Intraoral (NPL) (3) Platelet And Plasma Separator For Bone Graft Handling (ORG) (3) Bone Grafting Material, Animal Source (NPM) (2) Mesh, Surgical (FTM) (2) Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (OWY) (2)

Premarket Exempt

Yes No

Clear

DSM Biomedical Dental Bone Graft - M263300700806 Catalog Number :

Device Description : Porcine Anorganic Dental Bone Graft

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

DSM Biomedical Dental Bone Graft - M263300700907 Catalog Number :

Device Description : Porcine Anorganic Dental Bone Graft

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

NEOMEM® ECM - M26330074010 Catalog Number : NX1520

Device Description : Porcine Extracellular Matrix Dental Membrane

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

NEOMEM® ECM - M26330074020 Catalog Number : NX2030

Device Description : Porcine Extracellular Matrix Dental Membrane

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

NEOMEM® ECM - M26330074030 Catalog Number : NX3040

Device Description : Porcine Extracellular Matrix Dental Membrane

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

DSM Biomedical Centrifuge - M263640020808 Catalog Number :

Device Description : Centrifuge for preparation of platelet rich plasma

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Arthrex DX Reinforcement Matrix - M263ABS30001 Catalog Number : ABS-30001S

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : OWY, FTM

Prescription Use : Yes

Device Count : 1

Arthrex DX Reinforcement Matrix - M263ABS30002 Catalog Number : ABS-30002S

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : OWY, FTM

Prescription Use : Yes

Device Count : 1

Genius Concentration System - M263G00001K0 Catalog Number : G00001

Device Description : Centrifuge

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

GENIUS Platelet Rich Plasma (PRP) System - M263G1003008 Catalog Number : G10030

Device Description : Disposable Kit

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

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