Home GUDID 20326053112007 Regard™
Primary DI 20326053112007
Brand Regard™
Company RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model GS0238
Published 2019-01-01
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20326053112007 Package GS1 6 Not in Commercial Distribution 10326053112000 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20326053112007 20326053112007 10326053112000 10326053112000
GMDN Terms# Term, Definition table Term Definition General/plastic surgical procedure kit, non-medicated, single-use A collection of various sterile 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 945020902 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#