Perforated Cytoflex Ti-enforced C06-4101

GUDID D767C0641010

Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-Enforced® membranes with the exception of perforation. The perforated macro holes allow for direct vascularization across the membrane. Both the Ti-Enforced® and perforated Ti-Enforced® membranes are designed to achieve predictable outcomes for GBR procedures.

UNICARE BIOMEDICAL INC.

Pliable-polymer dental regeneration membrane, non-bioabsorbable

• Primary Device ID: D767C0641010
• NIH Device Record Key: bd18ed15-3bf9-416f-b878-09795c81c01d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perforated Cytoflex Ti-enforced
• Version Model Number: 32x40mm
• Catalog Number: C06-4101
• 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: true
• 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
• 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
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if packaged is damaged.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D767C0641010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151344

FDA Product Code

• NPK: Barrier, Synthetic, Intraoral

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-22
• Device Publish Date: 2024-07-12

On-Brand Devices [Perforated Cytoflex Ti-enforced]

• D767C0641010: Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-
• D767C0639010: Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-
• D767C0635010: Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-
• D767C0617010: Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-
• D767C0613010: Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-
• D767C0609010: Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-