Cytoplast™ Titanium-Reinforced PTFE Membranes

GUDID D765TI150BLN21

Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 25 mm

Osteogenics Biomedical Inc

Pliable-polymer dental regeneration membrane, non-bioabsorbable
Primary Device IDD765TI150BLN21
NIH Device Record Key12292048-0d47-4653-94cb-e235b6815008
Commercial Distribution StatusIn Commercial Distribution
Brand NameCytoplast™ Titanium-Reinforced PTFE Membranes
Version Model NumberTi150BL-N-2
Company DUNS123853058
Company NameOsteogenics Biomedical Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length25 Millimeter
Width17 Millimeter
Length25 Millimeter
Width17 Millimeter
Length25 Millimeter
Width17 Millimeter
Length25 Millimeter
Width17 Millimeter
Length25 Millimeter
Width17 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD765TI150BLN20 [Primary]
HIBCCD765TI150BLN21 [Package]
Contains: D765TI150BLN20
Package: [2 Units]
In Commercial Distribution

FDA Product Code

NPKBarrier, Synthetic, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-09
Device Publish Date2022-06-01

On-Brand Devices [Cytoplast™ Titanium-Reinforced PTFE Membranes]

D765TI250XLN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI250XLN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI250XLKN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced,30 mm x 40 mm
D765TI250XLKN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI250PTCN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI250PTCN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI250PSTN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm 36 mm
D765TI250PSTN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm
D765TI250PSN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm
D765TI250PSN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm
D765TI250PPN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm
D765TI250PPN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm
D765TI250PLTN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm
D765TI250PLTN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm
D765TI250PLN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm
D765TI250PLN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm
D765TI250PDN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI250PDN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI250K2N21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 40 mm x 50 mm
D765TI250K2N10Non-resorbable Textured PTFE Barrier Membranes, Titanium- Reinforced, 40 mm x 50 mm
D765TI250BLN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 25 mm
D765TI250BLN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 25 mm
D765TI250BLLN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 30 mm
D765TI250BLLN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 30 mm
D765TI250ATCN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 24 mm x 38 mm
D765TI250ASN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 14 mm x 24 mm
D765TI250ASN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 14 mm x 24 mm
D765TI250APN21Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 19 mm
D765TI250APN10Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 19 mm
D765TI250ANLN21Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 12 mm x 24 mm
D765TI250ANLN10Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 12 mm x 24 mm
D765TI250ANL30N21Non-Resorbable Textured PTFE Barrier Membrane, 12 mm x 30 mm
D765TI250ANL30N10Non-Resorbable Textured PTFE Barrier Membrane, 12 mm x 30 mm
D765TI150XLN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI150XLN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI150XLKN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI150XLKN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI150PTCN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI150PTCN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI150PSTN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm
D765TI150PSTN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm
D765TI150PSN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm
D765TI150PSN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm
D765TI150PLTN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm
D765TI150PLTN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm
D765TI150PLN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm
D765TI150PLN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm
D765TI150PDN21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI150PDN10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI150K2N21Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 40 mm x 50 mm

Trademark Results [Cytoplast]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CYTOPLAST
CYTOPLAST
87284533 5394296 Live/Registered
Osteogenics Biomedical, Inc.
2016-12-29
CYTOPLAST
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.