Home GUDID D767B0105081
BenaCel
Primary DI D767B0105081
Brand BenaCel
Company UNICARE BIOMEDICAL INC.
Model C-004
Catalog number B01-0408
Device description BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
Published 2021-07-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D767B0104081 Primary HIBCC 0 D767B0105081 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition General oral wound dressing, non-animal-derived, sterile A sterile device intended to be used as a protective cover for the general oral mucosa to treat surgical or traumatic wounds/lesions in the mouth. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home or a clinical setting. After application, this device cannot be reused.
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 8 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00368040753141 Promiseb Topical Cream Primus Pharmaceuticals, Inc. MGQ 2026-05-01 00850058790114 RV-X1 Gel4med, Inc. MGQ 2025-10-17 00850058790121 RV-X1 Gel4med, Inc. MGQ 2025-10-17 00850058790138 G4Derm Plus Gel4med, Inc. MGQ 2025-10-17 00850058790145 G4Derm Plus Gel4med, Inc. MGQ 2025-10-17 00850058790152 G4Derm Plus Gel4med, Inc. MGQ 2025-10-17 00383160000104 Dash Topic AIM MEDICAL INC. MGQ 2025-05-12 00850058790060 Suprello Gel4med, Inc. MGQ 2025-03-25 00850058790084 Suprello Gel4med, Inc. MGQ 2025-03-25 00850058790091 Suprello Gel4med, Inc. MGQ 2025-03-25 00860013569907 MuGard Soleva Pharma LLC MGQ 2025-02-28 00743537000791 BurnFree WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000814 BurnFree WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000838 BurnFree WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000852 Burn Stop WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000913 Water-Jel WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000937 Water-Jel WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000951 Water-Jel WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000975 Burn Stop WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000999 Water-Jel WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537001019 Water-Jel WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537001033 Water-Jel WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537001057 Water-Jel WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537001071 Burn Stop WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537001095 Water-Jel WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000784 BurnFree WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000807 BurnFree WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000821 BurnFree WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000845 Burn Stop WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01 00743537000906 Water-Jel WATER-JEL TECHNOLOGIES, L.L.C. MGQ 2024-11-01