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 10809160523063 Halyard AVID MEDICAL, INC. LRO 2026-06-09 10809160523070 Halyard AVID MEDICAL, INC. LRO 2026-06-09 10809160523094 Halyard AVID MEDICAL, INC. LRO 2026-06-09 10809160523100 Halyard AVID MEDICAL, INC. LRO 2026-06-09 10809160523124 Halyard AVID MEDICAL, INC. LRO 2026-06-09 10809160523131 Halyard AVID MEDICAL, INC. LRO 2026-06-09 10809160523223 Halyard AVID MEDICAL, INC. LRO 2026-06-09 10809160523230 Halyard AVID MEDICAL, INC. LRO 2026-06-09 10809160523247 Halyard AVID MEDICAL, INC. LRO 2026-06-09 10197106911266 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956359024 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956364783 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956429666 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956432048 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956433144 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956443518 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956466012 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956467484 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956469204 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956469624 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956473423 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956477193 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956477292 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956477339 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956483378 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956483903 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956484368 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956487406 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956492660 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08 10198956493667 CARDINAL HEALTH Cardinal Health 200, LLC LRO 2026-06-08