Unigraft U03-0205

GUDID D767U0302051

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
Primary Device IDD767U0302051
NIH Device Record Keyab98d2db-c9a9-46e9-9d3b-ca4120770558
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnigraft
Version Model Number200-600um 1.0g
Catalog NumberU03-0205
Company DUNS038023573
Company NameUNICARE BIOMEDICAL INC.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD767U030201 [Unit of Use]
HIBCCD767U0302051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYCBone Grafting Material, Synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-07-27
Device Publish Date2015-09-18

On-Brand Devices [Unigraft]

D767U0302051Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in
D767U0301051Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in
D767U0102051Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in
D767U0101051Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in

Trademark Results [Unigraft]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNIGRAFT
UNIGRAFT
75710295 2407291 Live/Registered
Unicare Biomedical, Inc.
1999-06-15

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