Home GUDID 10194717109440 Regard™
Primary DI 10194717109440
Brand Regard™
Company ROI CPS, LLC
Model GS00394H
Device description GENERAL ROBOTICS
Published 2021-02-02
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 LRP Tray, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRP Tray, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717109447 Package GS1 3 Not in Commercial Distribution 10194717109440 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717109447 20194717109447 10194717109440 10194717109440
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 00198506091278 ELMED INCORPORATED ELMED INCORPORATED LRP 2026-06-09 04052536163434 neon3 Ulrich GmbH & Co. KG LRP 2026-06-09 04052536164585 neon3 Ulrich GmbH & Co. KG LRP 2026-06-09 04052536164592 neon3 Ulrich GmbH & Co. KG LRP 2026-06-09 04052536164608 neon3 Ulrich GmbH & Co. KG LRP 2026-06-09 04052536177516 neon3 Ulrich GmbH & Co. KG LRP 2026-06-09 04052536221202 uCentum Ulrich GmbH & Co. KG LRP 2026-06-09 04052536221219 uCentum Ulrich GmbH & Co. KG LRP 2026-06-09 04052536221233 uCentum Ulrich GmbH & Co. KG LRP 2026-06-09 04052536162116 neon3 Ulrich GmbH & Co. KG LRP 2026-06-08 04052536162130 neon3 Ulrich GmbH & Co. KG LRP 2026-06-08 04052536162147 neon3 Ulrich GmbH & Co. KG LRP 2026-06-08 04052536162154 neon3 Ulrich GmbH & Co. KG LRP 2026-06-08 04052536162215 neon3 Ulrich GmbH & Co. KG LRP 2026-06-08 04052536176724 neon3 Ulrich GmbH & Co. KG LRP 2026-06-08 04052536176748 neon3 Ulrich GmbH & Co. KG LRP 2026-06-08 04052536176755 neon3 Ulrich GmbH & Co. KG LRP 2026-06-08 04052536176762 neon3 Ulrich GmbH & Co. KG LRP 2026-06-08 10198956433755 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956461109 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956476950 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956479999 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956485112 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956487475 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956490109 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956490635 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956494817 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956501362 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956505841 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08 10198956506381 CARDINAL HEALTH Cardinal Health 200, LLC LRP 2026-06-08