Home GUDID 10194717112488 Regard™
Primary DI 10194717112488
Brand Regard™
Company ROI CPS, LLC
Model GS00237H
Device description PK CUST LAP CHOLE
Published 2021-07-19
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 FDE Laparoscopy Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDE Laparoscopy Kit Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717112485 Package GS1 3 Not in Commercial Distribution 10194717112488 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717112485 20194717112485 10194717112488 10194717112488
GMDN Terms# Term, Definition table Term Definition Laparoscopic surgical procedure kit, non-medicated, single-use A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. 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 10080196887248 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2025-01-19 10080196926213 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2025-01-19 10193489213928 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2024-07-29 10080196498192 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-07-29 10080196498345 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-07-29 10193489211658 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-06-08 10193489212594 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-06-08 10193489213003 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-06-08 10193489213515 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-06-08 10193489214116 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-06-08 10193489214154 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-06-08 10193489215472 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-06-08 10193489216769 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2023-06-08 10193489287592 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489288285 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489288407 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489288414 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489289732 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489289749 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489289848 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489290059 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489290189 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489290196 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489290240 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489291049 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489291100 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489291155 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489291902 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489292114 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09 10193489292121 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FDE 2021-11-09