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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Regard™ - 10194717113485

EYE TRAY
ROI CPS, LLC
EY00099AE
Not in Commercial Distribution

  • 20194717113482 ()
  • 10194717113485 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717111559

EYE
ROI CPS, LLC
EY00036J
Not in Commercial Distribution

  • 20194717111556 ()
  • 10194717111559 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717111542

CATARACT
ROI CPS, LLC
EY00812G
Not in Commercial Distribution

  • 20194717111549 ()
  • 10194717111542 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717110774

EYE
ROI CPS, LLC
EY00808G
Not in Commercial Distribution

  • 20194717110771 ()
  • 10194717110774 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717120018

CATARACT
ROI CPS, LLC
EY01220C
Not in Commercial Distribution

  • 20194717120015 ()
  • 10194717120018 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717119135

CATARACT
ROI CPS, LLC
EY01220B
Not in Commercial Distribution

  • 20194717119132 ()
  • 10194717119135 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717119067

CATARACT
ROI CPS, LLC
EY00998D
Not in Commercial Distribution

  • 20194717119064 ()
  • 10194717119067 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717119005

EYE KIT
ROI CPS, LLC
EY00036K
Not in Commercial Distribution

  • 20194717119002 ()
  • 10194717119005 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717118596

VIRECTOMY BASIC
ROI CPS, LLC
EY00236S
Not in Commercial Distribution

  • 20194717118593 ()
  • 10194717118596 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717117957

VITRECTOMY
ROI CPS, LLC
EY00938E
Not in Commercial Distribution

  • 20194717117954 ()
  • 10194717117957 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
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