Home GUDID 20194717110467 Regard™
Primary DI 20194717110467
Brand Regard™
Company ROI CPS, LLC
Model ET01147
Device description RESTORATIVE DENTISTRY
Published 2021-05-03
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 OFW Restorative Instrument And Component Tray
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OFW Restorative Instrument And Component Tray Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717110467 Package GS1 11 In Commercial Distribution 10194717110460 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717110467 20194717110467 10194717110460 10194717110460
GMDN Terms# Term, Definition table Term Definition Dental/maxillofacial surgical procedure kit, non-medicated, single-use A collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.
Regulatory Flags# DUNS number 117174678 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true 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 10198956432109 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2026-05-08 10198956325388 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2026-03-16 50198956325386 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2026-03-16 10197106847596 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2024-12-20 10197106505762 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2024-02-02 50197106505760 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2024-02-02 10197106372876 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-07-19 50197106372874 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-07-19 10197106323892 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-06-15 50197106323890 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-06-15 10197106270974 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-05-11 50197106270972 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-05-11 10197106183878 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-03-10 50197106183876 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-03-10 10197106149409 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-02-17 50197106149407 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-02-17 10197106105719 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2023-01-19 10194717115083 Regard™ ROI CPS, LLC OFW 2022-03-21 20194717115080 Regard™ ROI CPS, LLC OFW 2022-03-21 10194717110460 Regard™ ROI CPS, LLC OFW 2021-05-03 10888439973976 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2021-01-04 50888439973974 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2021-01-04 10887488722412 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2017-04-25 50887488722410 CARDINAL HEALTH Cardinal Health 200, LLC OFW 2017-04-25