Cytoflex Textured Tef-Guard C04-0101

GUDID D767C0401051

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. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE), the textured version of Cytoflex® Tef-Guard® has superficial macro texture overlapping the micro pore texture on both surfaces. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. The macro texture provides additional grips for flap attachment.

UNICARE BIOMEDICAL INC.

Pliable-polymer dental regeneration membrane, non-bioabsorbable
Primary Device IDD767C0401051
NIH Device Record Keyf3430b1f-83d4-4971-b1c8-c6667dc7d64e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCytoflex Textured Tef-Guard
Version Model NumberTEX-100
Catalog NumberC04-0101
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 Degrees Celsius and 65 Degrees Celsius
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 Degrees Celsius and 65 Degrees Celsius
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 Degrees Celsius and 65 Degrees Celsius
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 Degrees Celsius and 65 Degrees Celsius
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 Degrees Celsius and 65 Degrees Celsius
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 Degrees Celsius and 65 Degrees Celsius
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 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD767C0401010 [Primary]
HIBCCD767C0401051 [Package]
Contains: D767C0401010
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 Textured Tef-Guard]

D767C0402010Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided
D767C0401051Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided

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