Home GUDID 20326053113110 Regard™
Primary DI 20326053113110
Brand Regard™
Company RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model GS0864
Published 2018-03-26
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name OXG Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OXG Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20326053113110 Package GS1 20 Not in Commercial Distribution 10326053113113 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20326053113110 20326053113110 10326053113113 10326053113113
GMDN Terms# Term, Definition table Term Definition Wound dressing kit, medicated, sterile A collection of sterile instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10326053113113 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. OXG 2018-03-26