Osteogenics Biomedical Inc

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

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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

Screw, Fixation, Intraosseous (DZL) (3) Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (NBY) (3) Bone Grafting Material, Synthetic (LYC) (2)

Premarket Exempt

No Yes

Clear

Surgiform® PTFE Suture - D765CS430S500 Catalog Number :

Device Description : Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 2-0, 50 m Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 2-0, 50 mm Straight Keith Needle

Device Class :

Duns Number: 123853058

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 1

Surgiform® PTFE Suture - D765CS430S50SS0 Catalog Number :

Device Description : Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 2-0, 50.8 Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 2-0, 50.8 mm Straight Keith Needle

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 1

Surgiform® PTFE Suture - D765CS518R130 Catalog Number :

Device Description : Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 3-0, 18 m Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 3-0, 18 mm 3/8 Circle Reverse Cutting Needle

Device Class :

Duns Number: 123853058

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 1

Cytoplast™ Non-Resorbable PTFE Barrier Membranes - D765GBR12240 Catalog Number :

Device Description : Nonresorbable PTFE Barrier Membrane, 12 mm x 24 mm

Device Class :

Duns Number: 123853058

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

Cytoplast™ Non-Resorbable PTFE Barrier Membranes - D765GBR25300 Catalog Number :

Device Description : Nonresorbable PTFE Barrier Membrane, 25 mm x 30 mm

Device Class :

Duns Number: 123853058

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

Resorba Suture Sample Pack - D765KIT0010 Catalog Number :

Device Class :

Duns Number: 123853058

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Ridge Preservation Kit - Cytoplast Technique - D765KITRPCT0 Catalog Number :

Device Description : Ridge Preservation Kit - Cytoplast Technique; Includes: 1 sterile nonresorbable Ridge Preservation Kit - Cytoplast Technique; Includes: 1 sterile nonresorbable PTFE monofilament suture (model CS0518K) - USP 3-0, 18" length,16 mm 3/8 reverse cutting needle, 1 sterile nonresorbable PTFE membrane, textured (model TXT1224K) - 12 mm x 24 mm, 1 sterile GBM allograft (model C73050K) - 70% mineralized cortical bone matrix & 30% demineralized bone matrix

Device Class :

Duns Number: 123853058

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Pro-fix™ Precision Fixation System - D765PFB100 Catalog Number :

Device Description : 1.5 mm x 10.0 mm self-tapping titanium alloy bone fixation screw

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 1

Pro-fix™ Precision Fixation System - D765PFB1051 Catalog Number :

Device Description : 1.5 mm x 10.0 mm self-tapping titanium alloy bone fixation screw

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 5

Pro-fix™ Precision Fixation System - D765PFB120 Catalog Number :

Device Description : 1.5 mm x 12.0 mm self-tapping titanium alloy bone fixation screw

Device Class : 2

Duns Number: 123853058

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 1

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