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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™ - 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™ - 10194717115953

VIRECTOMY
ROI CPS, LLC
EY00266J
Not in Commercial Distribution

  • 20194717115950 ()
  • 10194717115953 ()


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

Regard™ - 10194717115410

CATARACT
ROI CPS, LLC
EY01220
Not in Commercial Distribution

  • 20194717115417 ()
  • 10194717115410 ()


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

Regard™ - 10194717115373

VIRECTOMY
ROI CPS, LLC
EY00266I
Not in Commercial Distribution

  • 20194717115370 ()
  • 10194717115373 ()


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

Regard™ - 10194717115243

CATARACT POST OP
ROI CPS, LLC
EY00220D
Not in Commercial Distribution

  • 20194717115240 ()
  • 10194717115243 ()


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

Regard™ - 10194717114635

Cataract
ROI CPS, LLC
EY00450L
Not in Commercial Distribution

  • 20194717114632 ()
  • 10194717114635 ()


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