Home GUDID 20194717119132 Regard™
Primary DI 20194717119132
Brand Regard™
Company ROI CPS, LLC
Model EY01220B
Device description CATARACT
Published 2024-05-31
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 Product Codes# Code, Name table Code Name OJK Eye Tray
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OJK Eye Tray Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717119132 Package GS1 4 In Commercial Distribution 10194717119135 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717119132 20194717119132 10194717119135 10194717119135
GMDN Terms# Term, Definition table Term Definition Ophthalmic surgical procedure kit, non-medicated, single-use A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10198956227552 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-08 10198956418899 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-08 10198956475380 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-08 10198956475441 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-08 10198956475489 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-08 10198956477551 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-08 10198956489264 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-08 10198956498556 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-08 10198956501911 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-08 10198956470507 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-05 10198956490260 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-05 10198956491960 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-05 10198956492776 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-05 10198956493001 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-05 10198956493377 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-05 10198956495173 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-05 10198956496569 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-05 10198956499744 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-05 10198956397682 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-03 10198956417229 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-03 10198956478992 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-03 10198956487642 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-03 10197106817643 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-01 10198956351738 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-01 10198956407084 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-01 10198956410145 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-01 10198956418387 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-01 10198956421219 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-01 10198956421257 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-01 10198956439559 CARDINAL HEALTH Cardinal Health 200, LLC OJK 2026-06-01