Home GUDID D767U0302051
Unigraft
Primary DI D767U0302051
Brand Unigraft
Company UNICARE BIOMEDICAL INC.
Model 200-600um 1.0g
Catalog number U03-0205
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.
Published 2015-09-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name LYC Bone Grafting Material, Synthetic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LYC Bone Grafting Material, Synthetic Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D767U0302051 Primary HIBCC 0 D767U030201 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a dry, well ventilated environment. Keep out of sunlight. Storage Environment Humidity 0 Percent (%) Relative Humidity 65 Percent (%) Relative Humidity Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 038023573 Device count 5 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07640164360041 Gibson Healthcare Alloplast Degradable Solutions AG LYC 2024-03-05 07640164360065 Gibson Healthcare Alloplast Degradable Solutions AG LYC 2024-03-05 08720165038077 OsOpia RevisiOs B.V. LYC 2021-06-30 08809324764870 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764887 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764894 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764900 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764917 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764924 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764931 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764948 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764955 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764962 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764979 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764986 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764993 OSTEON Sinus GENOSS CO., Ltd. LYC 2018-07-10 08809324765006 OSTEON Sinus GENOSS CO., Ltd. LYC 2018-07-10 08809324765013 OSTEON Lifting GENOSS CO., Ltd. LYC 2018-07-10 08809324765020 OSTEON Lifting GENOSS CO., Ltd. LYC 2018-07-10 08809324765082 OSTEON ll Sinus GENOSS CO., Ltd. LYC 2018-07-10 08809324765105 OSTEON ll Sinus GENOSS CO., Ltd. LYC 2018-07-10 08809324765136 OSTEON ll Lifting GENOSS CO., Ltd. LYC 2018-07-10 08809324765174 OSTEON ll Lifting GENOSS CO., Ltd. LYC 2018-07-10 08809324768014 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768021 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768038 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768045 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768052 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768069 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768076 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10