Unigraft U01-0105
GUDID D767U0101051
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 ID | D767U0101051 |
| NIH Device Record Key | 9569fca7-8280-4c46-9620-37289f90ec6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unigraft |
| Version Model Number | 200-400um 0.4g |
| Catalog Number | U01-0105 |
| 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 |
| sales@unicarebiomedical.com | |
| Phone | 949-305-9600 |
| sales@unicarebiomedical.com | |
| Phone | 949-305-9600 |
| sales@unicarebiomedical.com | |
| Phone | 949-305-9600 |
| sales@unicarebiomedical.com | |
| Phone | 949-305-9600 |
| sales@unicarebiomedical.com | |
| Phone | 949-305-9600 |
| sales@unicarebiomedical.com | |
| Phone | 949-305-9600 |
| 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 | D767U010101 [Unit of Use] |
| HIBCC | D767U0101051 [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 |
Trademark Results [Unigraft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNIGRAFT 75710295 2407291 Live/Registered |
Unicare Biomedical, Inc. 1999-06-15 |
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