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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™ - 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

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

EVA NEXUS™ cartridge with 0,5 L collection bag - 08717872036625

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
9100.CAR01-00
In Commercial Distribution

  • 08717872036625 ()
  • 18717872036622 ()
9100.CAR01-00

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

Disposable EVA Drapes - 08717872036595

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8110.DRA01-00
In Commercial Distribution

  • 08717872036595 ()
  • 18717872036592 ()


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

Disposable High Speed Vitrectomy Prof-Pack for Associate (20 gauge / 0.9 mm) - 08717872009896

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
4210.ASC25
In Commercial Distribution

  • 08717872009896 ()
  • 18717872009893 ()
4210.ASC25

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