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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™ - 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
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