Unigraft U03-0105

GUDID D767U0301051

Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.

UNICARE BIOMEDICAL INC.

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: D767U0301051
• NIH Device Record Key: cad2c703-fb24-4aed-81df-49e69e4d01f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unigraft
• Version Model Number: 200-600um 0.4g
• Catalog Number: U03-0105
• Company DUNS: 038023573
• Company Name: UNICARE BIOMEDICAL INC.
• Device Count: 5
• 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	D767U030101 [Unit of Use]
HIBCC	D767U0301051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092567

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

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: 2015-09-18

On-Brand Devices [Unigraft]

• D767U0302051: Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in
• D767U0301051: Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in
• D767U0102051: Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in
• D767U0101051: Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in