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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

Disposable High Speed Vitrectomy Pack for Associate (20 gauge / 0.9 mm) - 08717872009735

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
4200.ASC25
In Commercial Distribution

  • 08717872009735 ()
  • 18717872009732 ()
4200.ASC25

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

Disposable High Speed Vitrectomy Cannula Pack for Associate (23 gauge / 0.6 mm) - 08717872009728

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
4200.ASC0E
In Commercial Distribution

  • 08717872009728 ()
  • 18717872009725 ()
4200.ASC0E

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

Disposable High Speed Vitrectomy Pack for Associate (23 gauge / 0.6 mm) - 08717872009711

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
4200.ASC06
In Commercial Distribution

  • 08717872009711 ()
  • 18717872009718 ()
4200.ASC06

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

Disposable phaco needle wrench for 3004.FD, 3005.FDS & 3005.FT - 08717872009032

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
3004.WD
In Commercial Distribution

  • 08717872009032 ()
  • 18717872009039 ()
3004.WD

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

Disposable Phaco Pack - 08717872008943

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
3002.P4
In Commercial Distribution

  • 08717872008943 ()
  • 18717872008940 ()
3002.P4

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

Disposable Phaco Pack - 08717872008929

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
3002.P2
Not in Commercial Distribution

  • 08717872008929 ()
  • 18717872008926 ()
3002.P2

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

Disposable Eckardt One step Vitrectomy Kit.(23 gauge / 0.6 mm) - 08717872002415

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1272.E2DIS
In Commercial Distribution

  • 08717872002415 ()
1272.E2DIS

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

EVA Custom TDC Vitrectomy Pack VGPC Input 27G - 08717872034720

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8527.402-00
In Commercial Distribution

  • 08717872034720 ()
  • 18717872034727 ()


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

EVA TDC Vitrectomy Pack VGPC Input 27G - 08717872034706

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8310.27G12-00
In Commercial Distribution

  • 18717872034703 ()
  • 08717872034706 ()
8310.27G12-00

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

EVA TDC Vitrectomy Pack VGPC Input 23G - 08717872034683

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8310.23G12-00
In Commercial Distribution

  • 18717872034680 ()
  • 08717872034683 ()
8310.23G12-00

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

EVA NEXUSTM Custom Phaco Pack 2.2mm 45 (Angled) - 08717872034379

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
9545.22AF1
In Commercial Distribution

  • 18717872034376 ()
  • 08717872034379 ()


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

EVA NEXUSTM Custom Phaco Pack 2.2mm 45 (Straight) - 08717872034362

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
9545.22SF1
In Commercial Distribution

  • 18717872034369 ()
  • 08717872034362 ()


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

EVA NEXUSTM Custom Phaco Pack 2.4mm 30 (Straight) - 08717872034331

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
9530.24SF1
In Commercial Distribution

  • 18717872034338 ()
  • 08717872034331 ()


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

EVA NEXUSTM Custom Phaco Pack 2.2mm 30 (Angled) - 08717872034317

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
9530.22AF1
In Commercial Distribution

  • 18717872034314 ()
  • 08717872034317 ()


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

EVA NEXUSTM Custom Phaco Pack 1.8mm 30 (Angled) - 08717872034294

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
9530.18AF1
In Commercial Distribution

  • 18717872034291 ()
  • 08717872034294 ()


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

EVA NEXUS™ Combined 23G TDC Pack - 08717872032856

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
9310.23G02
In Commercial Distribution

  • 18717872032853 ()
  • 08717872032856 ()


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

EVA Custom TDC Vitrectomy Pack VGPC Input 27G - 08717872032702

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8527.402
In Commercial Distribution

  • 18717872032709 ()
  • 08717872032702 ()
8527.402

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

EVA Custom TDC Vitrectomy Pack VGPC Input 25G - 08717872032672

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8525.406
In Commercial Distribution

  • 18717872032679 ()
  • 08717872032672 ()
8525.406

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

EVA TDC Vitrectomy Pack VGPC Input 27G - 08717872032238

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8310.27G12
In Commercial Distribution

  • 18717872032235 ()
  • 08717872032238 ()


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

EVA TDC Vitrectomy Pack Gravity Input 27G - 08717872032221

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8310.27G11
In Commercial Distribution

  • 18717872032228 ()
  • 08717872032221 ()


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

EVA TDC Vitrectomy Pack VGPC Input 25G - 08717872032191

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8310.25G12
In Commercial Distribution

  • 18717872032198 ()
  • 08717872032191 ()


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

EVA TDC Vitrectomy Pack Gravity Input 25G - 08717872032184

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8310.25G11
In Commercial Distribution

  • 18717872032181 ()
  • 08717872032184 ()


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

EVA TDC Vitrectomy Pack VGPC Input 23G - 08717872032177

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8310.23G12
In Commercial Distribution

  • 18717872032174 ()
  • 08717872032177 ()


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

EVA TDC Vitrectomy Pack Gravity Input 23G - 08717872032160

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8310.23G11
In Commercial Distribution

  • 18717872032167 ()
  • 08717872032160 ()


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

EVA Vitrectomy Pack VGPC Input 25G - 08717872032153

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8300.25G12
In Commercial Distribution

  • 18717872032150 ()
  • 08717872032153 ()


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

EVA Vitrectomy Pack Gravity Input 25G - 08717872032146

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8300.25G11
In Commercial Distribution

  • 18717872032143 ()
  • 08717872032146 ()


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

EVA Vitrectomy Pack VGPC Input 23G - 08717872032139

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8300.23G12
In Commercial Distribution

  • 18717872032136 ()
  • 08717872032139 ()


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

EVA Custom TDC Vitrectomy Pack VGPC Input 27G - 08717872031828

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8527.406
In Commercial Distribution

  • 18717872031825 ()
  • 08717872031828 ()


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

EVA Custom TDC Vitrectomy Pack VGPC Input 25G - 08717872031811

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8525.409
In Commercial Distribution

  • 18717872031818 ()
  • 08717872031811 ()


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

EVA Custom TDC Vitrectomy Pack VGPC Input 23G - 08717872031804

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8523.422
In Commercial Distribution

  • 18717872031801 ()
  • 08717872031804 ()


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