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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™ - 10194717110583

TOTAL HIP
ROI CPS, LLC
OR01152
In Commercial Distribution

  • 20194717110580 ()
  • 10194717110583 ()


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

Regard™ - 10194717110552

EXTREMITY
ROI CPS, LLC
OR01137
In Commercial Distribution

  • 20194717110559 ()
  • 10194717110552 ()


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

Regard™ - 10194717110545

ARTHROSCOPY
ROI CPS, LLC
OR01133
In Commercial Distribution

  • 20194717110542 ()
  • 10194717110545 ()


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

Regard™ - 10194717110453

TOTAL KNEE SURGICAL
ROI CPS, LLC
OR01151
In Commercial Distribution

  • 20194717110450 ()
  • 10194717110453 ()


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

Regard™ - 10194717110446

SHOULDER ARTHROSCOPY
ROI CPS, LLC
OR01148
In Commercial Distribution

  • 20194717110443 ()
  • 10194717110446 ()


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

Regard™ - 10194717110323

EXTREMITY
ROI CPS, LLC
OR00903A
In Commercial Distribution

  • 20194717110320 ()
  • 10194717110323 ()


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

Regard™ - 10194717110286

HAND TRAY CCOR
ROI CPS, LLC
OR00769L
In Commercial Distribution

  • 20194717110283 ()
  • 10194717110286 ()


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

Regard™ - 10194717110262

TOTAL HIP
ROI CPS, LLC
OR00733E
In Commercial Distribution

  • 20194717110269 ()
  • 10194717110262 ()


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

Regard™ - 10194717110248

HAND TRAY
ROI CPS, LLC
OR00429J
In Commercial Distribution

  • 20194717110245 ()
  • 10194717110248 ()


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

Regard™ - 10194717110217

EXTREMITY
ROI CPS, LLC
OR00180S
In Commercial Distribution

  • 20194717110214 ()
  • 10194717110217 ()


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