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

• Primary Device ID: D767C0103051
• NIH Device Record Key: e0f7b8cf-db5b-437f-8f5c-22d2d37d8ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytoflex Smooth Tef-Guard
• Version Model Number: TEF-001
• Catalog Number: C01-0301
• Company DUNS: 038023573
• Company Name: UNICARE 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

Customer Support Contacts

• Phone: 949-305-9600
• Email: sales@unicarebiomedical.com
• Phone: 949-305-9600
• Email: sales@unicarebiomedical.com
• Phone: 949-305-9600
• Email: sales@unicarebiomedical.com
• Phone: 949-305-9600
• Email: sales@unicarebiomedical.com
• Phone: 949-305-9600
• Email: sales@unicarebiomedical.com
• Phone: 949-305-9600
• Email: sales@unicarebiomedical.com
• Phone: 949-305-9600
• Email: sales@unicarebiomedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D767C0103010 [Primary]
HIBCC	D767C0103051 [Package]; Contains: D767C0103010; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012144

FDA Product Code

• NPK: Barrier, Synthetic, Intraoral

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-27
• Device Publish Date: 2016-11-23

On-Brand Devices [Cytoflex Smooth Tef-Guard]

• D767C0103051: Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided
• D767C0101051: Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided