Home GUDID 10194717115700
Regard™
Primary DI 10194717115700
Brand Regard™
Company ROI CPS, LLC
Model ET01068A
Device description ENT
Published 2022-04-14
Public version status Update
Distribution status Not 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 OGR Ear, Nose, And Throat Surgical Tray
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OGR Ear, Nose, And Throat Surgical Tray Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717115707 Package GS1 4 Not in Commercial Distribution 10194717115700 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717115707 20194717115707 10194717115700 10194717115700
GMDN Terms# Term, Definition table Term Definition ENT surgical procedure kit, non-medicated, single-use A collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.
Regulatory Flags# DUNS number 117174678 Device count 1 Premarket exempt true Kit true 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 10197106983577 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-08 10198956362932 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-08 10198956386150 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-08 10198956390430 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-08 10198956402683 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-08 10198956489424 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-08 10198956495203 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-08 10198956501676 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-08 10198956503809 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-08 10198956385795 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956423930 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956439269 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956444379 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956466272 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956472907 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956473201 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956487024 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956492004 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956492585 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956492790 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956498587 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956498792 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 10198956500563 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-05 B098AMS177290 Aligned Medical Solutions Aligned Medical Solutions OGR 2026-06-05 10198956443570 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-03 10198956479609 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-03 10198956490857 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-03 10198956492653 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-03 10198956494237 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-03 10198956497009 CARDINAL HEALTH Cardinal Health 200, LLC OGR 2026-06-03