Home GUDID 20326053113172 Regard™
Primary DI 20326053113172
Brand Regard™
Company RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model GU0869
Published 2017-05-18
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 20326053113172 Package GS1 3 Not in Commercial Distribution 10326053113175 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20326053113172 20326053113172 10326053113175 10326053113175
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 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#