ORTHOGEM LTD

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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

PURblue - 05051775000837 Catalog Number :

Device Description : PURblue CMX, 1-4mm granules, 5cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

PURblue - 05051775000844 Catalog Number :

Device Description : PURblue CMX, 1-4mm granules, 10cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

PURblue - 05051775000851 Catalog Number :

Device Description : PURblue CMX, 1-2mm granules, 5cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

PURblue - 05051775000868 Catalog Number :

Device Description : PURblue CMX, 1-2mm granules, 10cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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