Home GUDID 00841396119262 Harmonize
Primary DI 00841396119262
Brand Harmonize
Company Kerr Corporation
Model 36438
Device description Nanohybrid Universal Composite Restorative; Unidose; Shade C4 Dentin
Published 2017-05-04
Public version status Update
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 EBF Material, Tooth Shade, Resin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBF Material, Tooth Shade, Resin Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841396119262 Primary GS1 0 10841396119269 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841396119262 00841396119262 841396119262 0841396119262 10841396119269 10841396119269
GMDN Terms# Term, Definition table Term Definition Dental composite resin A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Weight 0.25 Gram
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at ambient temperature
Regulatory Flags# DUNS number 199354556 Device count 10 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 00815967025856 Rodin Pac-Dent, Inc. EBF 2026-03-24 00815967025863 Rodin Pac-Dent, Inc. EBF 2026-03-24 00815967025870 Rodin Pac-Dent, Inc. EBF 2026-03-24 00815967021438 OptiComp Pac-Dent, Inc. EBF 2026-03-23 00815967021797 OptiComp Pac-Dent, Inc. EBF 2026-03-23 00815967027447 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028161 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028178 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028185 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028192 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028208 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028215 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028222 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028239 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028246 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028253 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028260 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028277 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028284 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028291 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028307 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028314 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028321 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028338 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028345 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028352 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028369 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028376 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028383 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028390 Rodin Pac-Dent, Inc. EBF 2026-03-23
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