ORTHOGEM LTD

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) (10)

Premarket Exempt

No

Clear

TriPore - 05051775000271 Catalog Number :

Device Description : TriPore HA in MPA, 1-4mm granules, 8cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

TriPore - 05051775000288 Catalog Number :

Device Description : TriPore in MPA, 1-4mm granules, 12cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

TriPore - 05051775000318 Catalog Number :

Device Description : TriPore HA in bottle blister, 0.25-0.5mm ganules, 0.5cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

TriPore - 05051775000325 Catalog Number :

Device Description : TriPore HA in bottle blister, 0.25-0.5mm granules, 1cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

TriPore - 05051775000332 Catalog Number :

Device Description : TriPore HA in bottle blister, 0.25-0.5mm granules, 1.5cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

TriPore - 05051775000349 Catalog Number :

Device Description : TriPore HA in bottle blister, 0.5-0.85mm granules, 0.5cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

TriPore - 05051775000356 Catalog Number :

Device Description : TriPore HA in bottle blister, 0.5-0.85mm granules, 1cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

TriPore - 05051775000363 Catalog Number :

Device Description : TriPore HA in bottle blister 0.5-0.85mm granules, 1.5cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

TriPore - 05051775000370 Catalog Number :

Device Description : TriPore HA in bottle blister, 0.5-0.85mm granules, 2cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

TriPore - 05051775000387 Catalog Number :

Device Description : TriPore HA in bottle blister, 1-2mm granules, 1cc

Device Class : 2

Duns Number: 220574912

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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