Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced
GUDID D765TI250AS20
Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 14 mm x 24 mm
Osteogenics Biomedical Inc
Pliable-polymer dental regeneration membrane, non-bioabsorbable| Primary Device ID | D765TI250AS20 |
| NIH Device Record Key | f6a32e7d-c444-4e77-96b1-00fdba615067 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced |
| Version Model Number | Ti250AS-2 |
| Company DUNS | 123853058 |
| Company Name | Osteogenics Biomedical Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
| Length | 24 Millimeter |
| Width | 14 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D765TI250AS20 [Primary] |
| HIBCC | D765TI250AS21 [Package] Package: Box [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K972278
FDA Product Code
| LYC | Bone Grafting Material, Synthetic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-04-29 |
On-Brand Devices [Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced]
| D765TI250BL20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 25 mm |
| D765TI250AS20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 14 mm x 24 mm |
| D765TI250XLK20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced,30 mm x 40 mm |
| D765TI250XLK10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm |
| D765TI250XL20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm |
| D765TI250XL10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm |
| D765TI250PTC20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm |
| D765TI250PTC10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm |
| D765TI250PST20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm 36 mm |
| D765TI250PST10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm |
| D765TI250PS20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm |
| D765TI250PS10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm |
| D765TI250PP20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm |
| D765TI250PP10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm |
| D765TI250PLT20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm |
| D765TI250PLT10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm |
| D765TI250PL20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm |
| D765TI250PL10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm |
| D765TI250PD20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm |
| D765TI250PD10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm |
| D765TI250K220 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 40 mm x 50 mm |
| D765TI250K210 | Non-resorbable Textured PTFE Barrier Membranes, Titanium- Reinforced, 40 mm x 50 mm |
| D765TI250BL10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 25 mm |
| D765TI250ATC20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 24 mm x 38 mm |
| D765TI250ATC10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 24 mm x 38 mm |
| D765TI250AS10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 14 mm x 24 mm |
| D765TI250AP20 | Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 19 mm |
| D765TI250AP10 | Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 19 mm |
| D765TI250ANL3020 | Non-Resorbable Textured PTFE Barrier Membrane, 12 mm x 30 mm |
| D765TI250ANL3010 | Non-Resorbable Textured PTFE Barrier Membrane, 12 mm x 30 mm |
| D765TI250ANL20 | Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 12 mm x 24 mm |
| D765TI250ANL10 | Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 12 mm x 24 mm |
| D765TI150XLK20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm |
| D765TI150XLK10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm |
| D765TI150XL20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm |
| D765TI150XL10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm |
| D765TI150PTC20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm |
| D765TI150PTC10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm |
| D765TI150PST20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm |
| D765TI150PST10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm |
| D765TI150PS20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm |
| D765TI150PS10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm |
| D765TI150PP20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm |
| D765TI150PP10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm |
| D765TI150PLT20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm |
| D765TI150PLT10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm |
| D765TI150PL20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm |
| D765TI150PL10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm |
| D765TI150PD20 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm |
| D765TI150PD10 | Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm |
Trademark Results [Cytoplast]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYTOPLAST 87284533 5394296 Live/Registered |
Osteogenics Biomedical, Inc. 2016-12-29 |
 CYTOPLAST 75379702 2208908 Dead/Cancelled |
Osteogenics Biomedical, Inc. 1997-10-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.