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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™ - 10194717100744

No Description
ROI CPS, LLC
EY00812F
Not in Commercial Distribution

  • 20194717100741 ()
  • 10194717100744 ()


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

Regard™ - 10194717100720

No Description
ROI CPS, LLC
EY00808F
Not in Commercial Distribution

  • 20194717100727 ()
  • 10194717100720 ()


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

Regard™ - 10194717100270

No Description
ROI CPS, LLC
EY00266G
Not in Commercial Distribution

  • 20194717100277 ()
  • 10194717100270 ()


  • 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™ - 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
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