Home GUDID 20194717111631 Regard™
Primary DI 20194717111631
Brand Regard™
Company ROI CPS, LLC
Model GS00221I
Device description PK CUST MAJOR BASIN
Published 2021-06-22
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 Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717111631 Package GS1 4 In Commercial Distribution 10194717111634 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717111631 20194717111631 10194717111634 10194717111634
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#