Unigraft

Basic Information

• Brand Name: Unigraft
• Primary DI: D767U0302051
• Version / Model: 200-600um 1.0g
• Catalog Number: U03-0205
• Company Name: UNICARE BIOMEDICAL INC.
• Labeler DUNS: 038023573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2015-09-18
• Public Version: 4
• Public Version Date: 2021-07-27
• Public Version Status: Update
• Public Device Record Key: ab98d2db-c9a9-46e9-9d3b-ca4120770558

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone Grafting Material, Synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D767U0302051	HIBCC
Unit of Use	D767U030201	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092567	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 65 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry, well ventilated environment. Keep out of sunlight.
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius