Cytoflex Smooth Tef-Guard C01-0301

GUDID D767C0103051

Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications.

UNICARE 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
Primary Device IDD767C0103051
NIH Device Record Keye0f7b8cf-db5b-437f-8f5c-22d2d37d8ee5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCytoflex Smooth Tef-Guard
Version Model NumberTEF-001
Catalog NumberC01-0301
Company DUNS038023573
Company NameUNICARE BIOMEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Customer Support Contacts

Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD767C0103010 [Primary]
HIBCCD767C0103051 [Package]
Contains: D767C0103010
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPKBarrier, Synthetic, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-07-27
Device Publish Date2016-11-23

On-Brand Devices [Cytoflex Smooth Tef-Guard]

D767C0103051Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided
D767C0101051Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.