Home GUDID H668166210
Cora-Caine
Primary DI H668166210
Brand Cora-Caine
Company Keystone Industries
Model 16621
Catalog number 16621
Device description CORA-CAINE Denture Adhesive (36-4g)
Published 2022-11-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true
Product Codes# Code, Name table Code Name KOP ADHESIVE, DENTURE, KARAYA
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KOP Adhesive, Denture, Karaya Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H668166211 Primary HIBCC 0 H668166210 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Karaya denture adhesive An adhesive compound composed of karaya (a fine vegetable gum powder) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from moisture Special Storage Condition, Specify 0 0 Keep out of direct sunlight
Regulatory Flags# DUNS number 073503117 Device count 36 DM exempt false Premarket exempt true HCT/P false Kit false Combination product true 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 H668166211 Cora-Caine Keystone Industries KOP 2022-11-30