Cytoflex Mesh C02-4401

GUDID D767C0244010

Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product is designed for use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate bone augmentation through adequate fixation of the augmentation material. The thin, supple mesh conforms easily to tissue contours, and yet presents sufficient stiffness to maintain space over the bony defect.

UNICARE BIOMEDICAL INC.

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• Primary Device ID: D767C0244010
• NIH Device Record Key: 4e2396a8-4153-45c3-868f-35d0499c30f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytoflex Mesh
• Version Model Number: M4-400
• Catalog Number: C02-4401
• 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	D767C0244010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021511

FDA Product Code

• JEY: Plate, Bone

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 Mesh]

• D767C0245010: Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product
• D767C0244010: Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product
• D767C0241010: Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product
• D767C0243010: Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product
• D767C0242010: Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product