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

Filler, Bone Void, Calcium Compound (MQV) (4) Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation (OIS) (2) Pin, Fixation, Smooth (HTY) (1)

Premarket Exempt

Clear

BIO2 TECHNOLOGIES - B01010001321 Catalog Number :

Device Description : Vitrium PIP Standard Straight

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010002311 Catalog Number :

Device Description : VITRIUM CMEDIUM, 8 x 23

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : MQV, OIS

Prescription Use : Yes

Device Count : 1

Bio2 Technologies - B01010002321 Catalog Number :

Device Description : VITRIUM CLARGE, 8 x 23

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : MQV, OIS

Prescription Use : Yes

Device Count : 1

BIO2 TECHNOLOGIES - B0101000258 Catalog Number :

Device Description : Vitrium C Instruments

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BIO2 TECHNOLOGIES - B0101000259 Catalog Number :

Device Description : Vitrium E Instruments

Device Class : 2

Duns Number: 832629898

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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