Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced

GUDID D765TI150PST10

Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm

Osteogenics Biomedical Inc

Pliable-polymer dental regeneration membrane, non-bioabsorbable
Primary Device IDD765TI150PST10
NIH Device Record Key81549777-0d26-4d8b-a934-ad07816eff56
Commercial Distribution StatusIn Commercial Distribution
Brand NameCytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced
Version Model NumberTi150PST-1
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

Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 Millimeter
Length36 Millimeter
Width25 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
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
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
HIBCCD765TI150PST10 [Primary]

FDA Product Code

LYCBone Grafting Material, Synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-12-07
Device Publish Date2016-04-29

On-Brand Devices [Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced]

D765TI250BL20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 25 mm
D765TI250AS20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 14 mm x 24 mm
D765TI250XLK20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced,30 mm x 40 mm
D765TI250XLK10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI250XL20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI250XL10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI250PTC20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI250PTC10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI250PST20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm 36 mm
D765TI250PST10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm
D765TI250PS20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm
D765TI250PS10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm
D765TI250PP20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm
D765TI250PP10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm
D765TI250PLT20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm
D765TI250PLT10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm
D765TI250PL20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm
D765TI250PL10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm
D765TI250PD20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI250PD10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI250K220Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 40 mm x 50 mm
D765TI250K210Non-resorbable Textured PTFE Barrier Membranes, Titanium- Reinforced, 40 mm x 50 mm
D765TI250BL10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 25 mm
D765TI250ATC20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 24 mm x 38 mm
D765TI250ATC10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 24 mm x 38 mm
D765TI250AS10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 14 mm x 24 mm
D765TI250AP20Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 19 mm
D765TI250AP10Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 19 mm
D765TI250ANL3020Non-Resorbable Textured PTFE Barrier Membrane, 12 mm x 30 mm
D765TI250ANL3010Non-Resorbable Textured PTFE Barrier Membrane, 12 mm x 30 mm
D765TI250ANL20Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 12 mm x 24 mm
D765TI250ANL10Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 12 mm x 24 mm
D765TI150XLK20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI150XLK10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI150XL20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI150XL10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 40 mm
D765TI150PTC20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI150PTC10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI150PST20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm
D765TI150PST10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 36 mm
D765TI150PS20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm
D765TI150PS10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm
D765TI150PP20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm
D765TI150PP10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 18 mm
D765TI150PLT20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm
D765TI150PLT10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm
D765TI150PL20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm
D765TI150PL10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 25 mm x 30 mm
D765TI150PD20Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 mm
D765TI150PD10Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 38 mm x 38 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.