Home GUDID 10194717100355 Regard™
Primary DI 10194717100355
Brand Regard™
Company ROI CPS, LLC
Model UR00279I
Published 2019-10-28
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 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 20194717100352 Package GS1 12 Not in Commercial Distribution 20194717105968 Package GS1 8 Not in Commercial Distribution 10194717100355 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717100352 20194717100352 20194717105968 20194717105968 10194717100355 10194717100355
GMDN Terms# Term, Definition table Term Definition General surgical procedure kit, non-medicated, single-use A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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 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