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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™ - 10194717110095

EYE TRAY
ROI CPS, LLC
EY00099AD
Not in Commercial Distribution

  • 20194717110092 ()
  • 10194717110095 ()


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

Regard™ - 10194717109976

EYE PK
ROI CPS, LLC
EY00916C
Not in Commercial Distribution

  • 20194717109973 ()
  • 10194717109976 ()


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

Regard™ - 10194717109297

VITRECTOMY
ROI CPS, LLC
EY00938C
Not in Commercial Distribution

  • 20194717109294 ()
  • 10194717109297 ()


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

Regard™ - 10194717109242

BASIC CATARACT
ROI CPS, LLC
EY00792G
Not in Commercial Distribution

  • 20194717109249 ()
  • 10194717109242 ()


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

Regard™ - 10194717107606

No Description
ROI CPS, LLC
EY00099AC
Not in Commercial Distribution

  • 20194717107603 ()
  • 10194717107606 ()


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

Regard™ - 10194717105381

No Description
ROI CPS, LLC
EY00998B
Not in Commercial Distribution

  • 20194717105388 ()
  • 10194717105381 ()


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

Regard™ - 10194717104995

No Description
ROI CPS, LLC
EY00792F
Not in Commercial Distribution

  • 20194717104992 ()
  • 10194717104995 ()


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

Regard™ - 10194717104643

No Description
ROI CPS, LLC
EY00450K
Not in Commercial Distribution

  • 20194717104640 ()
  • 10194717104643 ()


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

Regard™ - 10194717104629

No Description
ROI CPS, LLC
EY00448C
Not in Commercial Distribution

  • 20194717104626 ()
  • 10194717104629 ()


  • 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
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