BIOSTRUCTURES, LLC

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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

Filler, Bone Void, Calcium Compound (MQV) (4)

Premarket Exempt

Clear

OsteoMatrix - 00852371006088 Catalog Number : OMCS10

Device Description : Mineralized Collagen Scaffold

Device Class : 2

Duns Number: 827042487

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoMatrix - 00852371006095 Catalog Number : OMCS05

Device Description : Mineralized Collagen Scaffold

Device Class : 2

Duns Number: 827042487

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Silhouette - 00852371006101 Catalog Number : SIL-180

Device Description : Mineralized Collagen Strip

Device Class : 2

Duns Number: 827042487

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Silhouette - 00852371006118 Catalog Number : SIL-090

Device Description : Mineralized Collagen Strip

Device Class : 2

Duns Number: 827042487

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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