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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™ - 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

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™ - 10194717110774

EYE
ROI CPS, LLC
EY00808G
Not in Commercial Distribution

  • 20194717110771 ()
  • 10194717110774 ()


  • 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

Regard™ - 10194717112181

CATARACT
ROI CPS, LLC
EY00998C
Not in Commercial Distribution

  • 20194717112188 ()
  • 10194717112181 ()


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

Medical Action Industries - 10809160026540

No Description
MEDICAL ACTION INDUSTRIES INC.
80803
Not in Commercial Distribution

  • 20809160026547 ()
  • 10809160026540 ()


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

Medical Action Industries - 10809160020456

Kit: Retina Injection 20/Cs
MEDICAL ACTION INDUSTRIES INC.
74690B
In Commercial Distribution

  • 20809160020453 ()
  • 10809160020456 ()


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