Home GUDID 20194717109539 Regard™
Primary DI 20194717109539
Brand Regard™
Company ROI CPS, LLC
Model GS01116A
Device description OBESE PRONE POSITIONING BUNDLE
Published 2021-01-27
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 LRO General Surgery Tray
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRO General Surgery Tray General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717109539 Package GS1 20 In Commercial Distribution 10194717109532 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717109539 20194717109539 10194717109532 10194717109532
GMDN Terms# Term, Definition table Term Definition General/plastic surgical procedure kit, non-medicated, single-use A collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain 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 H65857029125 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-09 H65857029135 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-09 H65857029145 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-09 H65857029165 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-09 H65857029105 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-08 H65857029115 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-08 H65857029095 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-04 H65857029005 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-31 H65857028265 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-28 H65857028255 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857028285 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029045 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029055 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029065 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029075 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029085 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857028925 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-26 H65857028935 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-25 H65857028945 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-25 H65857028915 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028965 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028975 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028985 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028995 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857029015 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028905 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-18 H65857028875 Henry Schein HENRY SCHEIN, INC. LRO 2021-12-29 H65857028865 Henry Schein HENRY SCHEIN, INC. LRO 2021-12-21 H65857028855 Henry Schein HENRY SCHEIN, INC. LRO 2021-12-14 H65857028845 Henry Schein HENRY SCHEIN, INC. LRO 2021-12-13