Home GUDID 20194717117817 Regard™
Primary DI 20194717117817
Brand Regard™
Company ROI CPS, LLC
Model GS00794N
Device description LAPAROSCOPY
Published 2023-09-13
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 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 20194717117817 Package GS1 3 In Commercial Distribution 10194717117810 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717117817 20194717117817 10194717117810 10194717117810
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 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 10653160393702 MEDLINE MEDLINE INDUSTRIES, INC. LRO 2026-05-27 10653160393757 CENTURION CENTURION MEDICAL PRODUCTS CORPORATION LRO 2026-05-27 10809160521878 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160521885 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160521892 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160521922 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160521939 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160521946 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160521953 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160521960 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160521977 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160521991 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160522004 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160522011 Halyard AVID MEDICAL, INC. LRO 2026-05-27 10809160522028 Halyard AVID MEDICAL, INC. LRO 2026-05-27 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 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 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