Home GUDID 20194717115561 Regard™
Primary DI 20194717115561
Brand Regard™
Company ROI CPS, LLC
Model GS00238I
Device description GENERAL PROCEDURE
Published 2022-04-14
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 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 20194717115561 Package GS1 6 In Commercial Distribution 10194717115564 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717115561 20194717115561 10194717115564 10194717115564
GMDN Terms# Term, Definition table Term Definition General/plastic surgical procedure kit, non-medicated, single-use A collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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 07649988948725 SPIRECUT SPIRECUT SA LRP 2026-05-04 G586961003A0 Novo Surgical NOVO SURGICAL, INC. LRP 2024-02-22 G429MSS820160 Stainless steel bowl small 6CM MEED SKILL SURGICAL LRP 2023-03-03 G141588222990 Carnegie Surgical LLC Carnegie Surgical LLC LRP 2023-02-13 07899798205796 Quinelato Schobell Industrial Ltda LRP 2022-12-20 10080196055159 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10080196818778 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10080196848041 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10080196996681 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10190001934897 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489190021 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489190076 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489190137 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489190304 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489190342 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489190380 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489190489 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489190564 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489191066 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489191073 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489191080 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489191097 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489191103 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489191141 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489191189 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489191240 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2022-01-01 10193489190199 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2021-12-16 10193489190205 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2021-12-16 10193489190212 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2021-12-16 10193489190250 MEDLINE MEDLINE INDUSTRIES, INC. LRP 2021-12-16