Cytoflex Resorb C03-0201

GUDID D767C0302010

Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure.

UNICARE BIOMEDICAL INC.

Pliable-polymer dental regeneration membrane, bioabsorbable, ligated Pliable-polymer dental regeneration membrane, bioabsorbable, ligated Pliable-polymer dental regeneration membrane, bioabsorbable, ligated Pliable-polymer dental regeneration membrane, bioabsorbable, ligated Pliable-polymer dental regeneration membrane, bioabsorbable, ligated Pliable-polymer dental regeneration membrane, bioabsorbable, ligated Pliable-polymer dental regeneration membrane, bioabsorbable, ligated

• Primary Device ID: D767C0302010
• NIH Device Record Key: 4ef69d60-26c2-4d10-a78a-15b949796aad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytoflex Resorb
• Version Model Number: 20x25mm
• Catalog Number: C03-0201
• 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	D767C0302010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090083

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: 2015-09-24

On-Brand Devices [Cytoflex Resorb]

• D767C0303010: Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb mem
• D767C0302010: Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb mem
• D767C0301010: Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb mem