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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™ - 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™ - 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™ - 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

Regard™ - 10194717112181

CATARACT
ROI CPS, LLC
EY00998C
Not in Commercial Distribution

  • 20194717112188 ()
  • 10194717112181 ()


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

RC Kit 2 - 05060745558063

No Description
BLINK MEDICAL LIMITED
67-0010
In Commercial Distribution

  • 05060745558070 ()
  • 05060745558063 ()


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

RC Kit 1 - 05060745558049

No Description
BLINK MEDICAL LIMITED
67-0018
In Commercial Distribution

  • 05060745558056 ()
  • 05060745558049 ()


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

Stockton Kit #1 - 05060745557738

No Description
BLINK MEDICAL LIMITED
67-0017
In Commercial Distribution

  • 05060745557745 ()
  • 05060745557738 ()


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

Stockton Kit #2 - 05060745557714

No Description
BLINK MEDICAL LIMITED
67-0014
In Commercial Distribution

  • 05060745557721 ()
  • 05060745557714 ()


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

Cannula Kit 1 - Kaiser Permanente Martinez - 05060745557219

No Description
BLINK MEDICAL LIMITED
67-0009
In Commercial Distribution

  • 05060745557226 ()
  • 05060745557219 ()


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

USA Universal Cataract Inst Set - 05060745555840

No Description
BLINK MEDICAL LIMITED
76-0026A
In Commercial Distribution

  • 05060745555857 ()
  • 05060745555840 ()


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

Foreign Body Removal Set - 05060745557110

No Description
BLINK MEDICAL LIMITED
76-0073
In Commercial Distribution

  • 05060745557127 ()
  • 05060745557110 ()


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

I² Kit for intraocular injection - B384VS05201

Intraocular injection kit - standard set with drape (speculum, marker, drape, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe)
Vortex Surgical, Inc.
VS0520
In Commercial Distribution

  • B384VS05201 ()
VS0520

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

I² Kit for intraocular injection - B384VS05101

Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe)
Vortex Surgical, Inc.
VS0510
In Commercial Distribution

  • B384VS05101 ()
VS0510

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

I² Kit for intraocular injection - B384VS05001

Intraocular Injection Kit - contains blade speculum and scleral marker
Vortex Surgical, Inc.
VS0500
In Commercial Distribution

  • B384VS05001 ()
VS0500

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

Oertli® - 07630003915709

PHACO PACK FAROS/CR3/SWISSTECH; SLEEVE (FOR EASYTIP 2.2MM),; TEST CHAMBER, TUBING SYSTEM
Oertli-Instrumente AG
VV621011DEC
In Commercial Distribution

  • 07630003915716 ()
  • 07630003915709 ()


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

Oertli® - 07630003913064

PHACO PACK FAROS/CR3/SWISSTECH; EASYTIP 2.2MM 30°, 2 SLEEVES,; TEST CHAMBER, INFUSION SET
Oertli-Instrumente AG
VV621011DEB2
In Commercial Distribution

  • 07630003913064 ()
  • 07630003913637 ()


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

Oertli® - 07630003910759

PHACO PACK FAROS/CR3/SWISSTECH; EASYTIP 2.2MM 40°, 2 SLEEVES; TEST CHAMBER, INFUSION SET
Oertli-Instrumente AG
VV621011DE2
In Commercial Distribution

  • 07630003910759 ()
  • 07630003913620 ()


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

Oertli® - 07630003910124

PHACO PACK FAROS/CR3/SWISSTECH; EASYTIP 2.8MM 30°, SLEEVE,; TEST CHAMBER, INFUSION SET
Oertli-Instrumente AG
VV621011AE
In Commercial Distribution

  • 07630003910124 ()
  • 07630003913590 ()


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

Oertli® - 07630003910094

PHACO PACK FAROS/CR3/SWISSTECH; EASYTIP 2.2MM 40°, SLEEVE,; INFUSION SET, I/A BIMANUAL
Oertli-Instrumente AG
VV621011DB
In Commercial Distribution

  • 07630003910094 ()
  • 07630003913606 ()


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

Oertli® - 07630003909852

PHACO PACK FAROS/CR3/SWISSTECH; EASYTIP CO-MICS 53°, 2 SLEEVES; TEST CHAMBER, INFUSION SET
Oertli-Instrumente AG
VV621111CE2
In Commercial Distribution

  • 07630003909852 ()
  • 07630003913651 ()


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