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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™ - 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™ - 10194717116653

VITRECTOMY
ROI CPS, LLC
EY00938D
Not in Commercial Distribution

  • 20194717116650 ()
  • 10194717116653 ()


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

Regard™ - 10194717116592

EYE TRAY
ROI CPS, LLC
EY00099AG
Not in Commercial Distribution

  • 20194717116599 ()
  • 10194717116592 ()


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

Regard™ - 10194717116486

PEDIATRIC EYE
ROI CPS, LLC
EY00933C
Not in Commercial Distribution

  • 20194717116483 ()
  • 10194717116486 ()


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

Regard™ - 10194717116431

RETINAL PACK
ROI CPS, LLC
EY00935D
Not in Commercial Distribution

  • 20194717116438 ()
  • 10194717116431 ()


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

Regard™ - 10194717116417

Cataract
ROI CPS, LLC
EY00450M
Not in Commercial Distribution

  • 20194717116414 ()
  • 10194717116417 ()


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

Regard™ - 10194717116110

EYE TRAY
ROI CPS, LLC
EY00099AF
Not in Commercial Distribution

  • 20194717116117 ()
  • 10194717116110 ()


  • 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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