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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™ - 10194717111795

TOT KNEE A&B
ROI CPS, LLC
OR00011S
Not in Commercial Distribution

  • 20194717111792 ()
  • 10194717111795 ()


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

Regard™ - 10194717109235

TOTAL KNEE A&B
ROI CPS, LLC
OR00799I
Not in Commercial Distribution

  • 20194717109232 ()
  • 10194717109235 ()


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

Regard™ - 10194717121855

CV 2 A&B
ROI CPS, LLC
CV01003Q
Not in Commercial Distribution

  • 20194717121852 ()
  • 10194717121855 ()


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

Regard™ - 10194717121602

OPEN HRT A&B
ROI CPS, LLC
CV00283O
Not in Commercial Distribution

  • 20194717121609 ()
  • 10194717121602 ()


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

Regard™ - 10194717120476

TOTAL KNEE A&B
ROI CPS, LLC
OR00799J
Not in Commercial Distribution

  • 20194717120473 ()
  • 10194717120476 ()


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

Regard™ - 10194717119999

CV 2 A&B
ROI CPS, LLC
CV01003P
Not in Commercial Distribution

  • 20194717119996 ()
  • 10194717119999 ()


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

Regard™ - 10194717119869

CV 2 A&B
ROI CPS, LLC
CV01003O
Not in Commercial Distribution

  • 20194717119866 ()
  • 10194717119869 ()


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

Regard™ - 10194717117414

CV 2 A&B
ROI CPS, LLC
CV01003N
Not in Commercial Distribution

  • 20194717117411 ()
  • 10194717117414 ()


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

Regard™ - 10194717117094

TOT KNEE A&B
ROI CPS, LLC
OR00011T
Not in Commercial Distribution

  • 20194717117091 ()
  • 10194717117094 ()


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

Regard™ - 10194717117001

TOT KNEE A & B
ROI CPS, LLC
OR00031X
Not in Commercial Distribution

  • 20194717117008 ()
  • 10194717117001 ()


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