Home GUDID 10194717115175 Regard™
Primary DI 10194717115175
Brand Regard™
Company ROI CPS, LLC
Model CV00256LM
Device description PERIPHERAL VASC
Published 2022-03-23
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 OEZ Cardiovascular Procedure Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OEZ Cardiovascular Procedure Kit Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717115172 Package GS1 2 Not in Commercial Distribution 10194717115175 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717115172 20194717115172 10194717115175 10194717115175
GMDN Terms# Term, Definition table Term Definition Cardiothoracic surgical procedure kit, non-medicated, single-use A collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. 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 H65857031555 Henry Schein HENRY SCHEIN, INC. OEZ 2022-08-25 H65857031565 Henry Schein HENRY SCHEIN, INC. OEZ 2022-08-25 H65857031315 Henry Schein HENRY SCHEIN, INC. OEZ 2022-08-10 H65857030865 Henry Schein HENRY SCHEIN, INC. OEZ 2022-05-25 H65857029425 Henry Schein HENRY SCHEIN, INC. OEZ 2022-03-31 H65857029535 Henry Schein HENRY SCHEIN, INC. OEZ 2022-03-31 10193489040166 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040180 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040197 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040203 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040210 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040227 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040234 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040241 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040258 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040265 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040272 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040289 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040296 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040302 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040319 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040326 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040333 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040340 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040357 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040364 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040371 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040388 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040395 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040401 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28