Home GUDID 10194717121305 Regard™
Primary DI 10194717121305
Brand Regard™
Company ROI CPS, LLC
Model GS01065D
Device description BREAST MAJOR CCOR
Published 2025-01-21
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 20194717121302 Package GS1 2 Not in Commercial Distribution 10194717121305 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717121302 20194717121302 10194717121305 10194717121305
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 10809160541111 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541128 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541166 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541173 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541203 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541227 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541234 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541258 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541289 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541319 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541326 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10809160541333 Halyard AVID MEDICAL, INC. LRO 2026-10-22 10885632541131 SurgiTrackSM OWENS & MINOR DISTRIBUTION, INC. LRO 2026-10-22 10809160540992 Halyard AVID MEDICAL, INC. LRO 2026-10-21 10809160541012 HALYARD AVID MEDICAL, INC. LRO 2026-10-21 10809160541050 Medical Action Industries MEDICAL ACTION INDUSTRIES INC. LRO 2026-10-21 10809160541081 Halyard AVID MEDICAL, INC. LRO 2026-10-21 10809160541098 Halyard AVID MEDICAL, INC. LRO 2026-10-21 10809160541104 Halyard AVID MEDICAL, INC. LRO 2026-10-21 10809160540862 Halyard AVID MEDICAL, INC. LRO 2026-10-20 10809160540886 Halyard AVID MEDICAL, INC. LRO 2026-10-20 10809160540916 Halyard AVID MEDICAL, INC. LRO 2026-10-20 10809160540923 Halyard AVID MEDICAL, INC. LRO 2026-10-20 10809160540930 Halyard AVID MEDICAL, INC. LRO 2026-10-20 10809160540947 Halyard AVID MEDICAL, INC. LRO 2026-10-20 10809160540954 Halyard AVID MEDICAL, INC. LRO 2026-10-20 10809160540961 Halyard AVID MEDICAL, INC. LRO 2026-10-20 10809160540978 Halyard AVID MEDICAL, INC. LRO 2026-10-20 10809160540985 Halyard AVID MEDICAL, INC. LRO 2026-10-20 00748426262069 Medline-Microtek Microtek Medical LLC LRO 2026-10-19