Osteogenics Biomedical Inc

Address:4620 71st St Bldg 78-79,LUBBOCK,TX,79424,US

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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

Bone Grafting Material, Animal Source (NPM) (10)

Premarket Exempt

No Yes

Clear

ZCORE FORM - D765ZF2000 Catalog Number :

Device Description : Moldable Collagen-Enriched Porcine Xenograft, Particle Size 0.25-1.0 mm, Sterile Moldable Collagen-Enriched Porcine Xenograft, Particle Size 0.25-1.0 mm, Sterile, Contents: 2.0 cc

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

ZCORE - D765ZL1000 Catalog Number :

Device Description : Porcine Xenograft Particulate, Particle Size 1.0-2.0mm, Sterile, Contents: 1.0cc

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

ZCORE - D765ZL2000 Catalog Number :

Device Description : Porcine Xenograft Particulate, Particle Size 1.0-2.0mm, Sterile, Contents: 2.0cc

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

ZCORE - D765ZS0500 Catalog Number :

Device Description : Porcine Xenograft Particulate, Particle Size 0.25-1.0mm, Sterile, Contents: 0.5cc

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

ZCORE - D765ZS1000 Catalog Number :

Device Description : Porcine Xenograft Particulate, Particle Size 0.25-1.0mm, Sterile, Contents: 1.0cc

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

ZCORE - D765ZS2000 Catalog Number :

Device Description : Porcine Xenograft Particulate, Particle Size 0.25-1.0mm, Sterile, Contents: 2.0cc

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

ZCORE - D765ZS4000 Catalog Number :

Device Description : Porcine Xenograft Particulate, Particle Size 0.25-1.0mm, Sterile, Contents: 4.0cc

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

ZCORE™ EXPAND - D765ZXSINUSL0 Catalog Number :

Device Description : Expandable Collagen-Enriched Porcine Xenograft (Large Sinus), 12 mm x 17 mm

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

ZCORE™ EXPAND - D765ZXSINUSS0 Catalog Number :

Device Description : Expandable Collagen-Enriched Porcine Xenograft (Small Sinus), 10 mm x 13 mm

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

ZCORE™ EXPAND - D765ZXSOCKET0 Catalog Number :

Device Description : Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NPM

Prescription Use : Yes

Device Count : 1

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