BIO2 TECHNOLOGIES, INC.

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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

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation (OIS) (10) Filler, Bone Void, Calcium Compound (MQV) (10)

Premarket Exempt

Clear

Bio2 Technologies - B01010000451 Catalog Number :

Device Description : VITRIUM E20 x 9

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : OIS, MQV

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010000461 Catalog Number :

Device Description : VITRIUM E20 x 10

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : OIS, MQV

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010000471 Catalog Number :

Device Description : VITRIUM E22 x 5

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : OIS, MQV

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010000481 Catalog Number :

Device Description : VITRIUM E22 x 6

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : OIS, MQV

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010000491 Catalog Number :

Device Description : VITRIUM E22 x 7

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : OIS, MQV

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010000501 Catalog Number :

Device Description : VITRIUM E22 x 8

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : OIS, MQV

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010000511 Catalog Number :

Device Description : VITRIUM E22 x 9

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : OIS, MQV

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010000521 Catalog Number :

Device Description : VITRIUM E22 x 10

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : OIS, MQV

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010000531 Catalog Number :

Device Description : VITRIUM CMEDIUM, 4 x 16

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : MQV, OIS

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010000541 Catalog Number :

Device Description : VITRIUM CMEDIUM, 5 x 16

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : MQV, OIS

Prescription Use : Yes

Device Count : 1

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