Cytoplast™ Non-Resorbable PTFE Barrier Membranes
GUDID D765GBR25300
Nonresorbable PTFE Barrier Membrane, 25 mm x 30 mm
Osteogenics Biomedical Inc
Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable| Primary Device ID | D765GBR25300 |
| NIH Device Record Key | 4eed35f0-bc6e-43d0-b147-8d5d71fa3bba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cytoplast™ Non-Resorbable PTFE Barrier Membranes |
| Version Model Number | GBR2530 |
| Company DUNS | 123853058 |
| Company Name | Osteogenics Biomedical Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D765GBR25300 [Primary] |
| HIBCC | D765GBR25301 [Package] Package: Box [4 Units] In Commercial Distribution |
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 | 2020-12-07 |
| Device Publish Date | 2016-04-29 |
On-Brand Devices [Cytoplast™ Non-Resorbable PTFE Barrier Membranes]
| D765TXT253010 | Nonresorbable Textured PTFE Barrier Membrane, 12 mm x 24 mm |
| D765TXT25300 | Nonresorbable Textured PTFE Barrier Membrane, 12 mm x 24 mm |
| D765TXT1224K0 | Nonresorbable Textured Barrier Membrane, 12 mm x 24 mm |
| D765TXT122410 | Nonresorbable Textured PTFE Barrier Membrane, 12 mm x 24 mm |
| D765TXT12240 | Nonresorbable Textured Barrier Membrane, 12 mm x 24 mm |
| D765TXT122010 | Nonresorbable PTFE Barrier Membrane, 12 mm x 20 mm |
| D765TXT12200 | Nonresorbable PTFE Barrier Membrane, 12 mm x 20 mm |
| D765GBR25300 | Nonresorbable PTFE Barrier Membrane, 25 mm x 30 mm |
| D765GBR12240 | Nonresorbable PTFE Barrier Membrane, 12 mm x 24 mm |
| D765TXT123010 | Nonresorbable Textured PTFE Barrier Membrane, 12 mm x 30 mm |
| D765TXT12300 | Nonresorbable Textured Barrier Membrane, 12 mm x 30 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 |
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