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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™ - 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

Regard™ - 10194717117797

CATARACT
ROI CPS, LLC
EY01220A
Not in Commercial Distribution

  • 20194717117794 ()
  • 10194717117797 ()


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

Regard™ - 10194717117360

VIRECTOMY
ROI CPS, LLC
EY00266K
Not in Commercial Distribution

  • 20194717117367 ()
  • 10194717117360 ()


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

Regard™ - 10194717117056

VIRECTOMY BASIC
ROI CPS, LLC
EY00236R
Not in Commercial Distribution

  • 20194717117053 ()
  • 10194717117056 ()


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

Regard™ - 10194717116653

VITRECTOMY
ROI CPS, LLC
EY00938D
Not in Commercial Distribution

  • 20194717116650 ()
  • 10194717116653 ()


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