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 10809160537855 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537862 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537879 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537886 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537893 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537909 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537916 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537923 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537930 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537947 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537954 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537961 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537985 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537992 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160538005 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160538029 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160538036 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160538043 Halyard AVID MEDICAL, INC. LRO 2026-09-20 10809160537541 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537558 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537572 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537589 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537596 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537602 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537640 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537664 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537688 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537695 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537701 Halyard AVID MEDICAL, INC. LRO 2026-09-19 10809160537732 Halyard AVID MEDICAL, INC. LRO 2026-09-19