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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™ - 10194717115946

CABG PACK A AND B
ROI CPS, LLC
CV00361R
Not in Commercial Distribution

  • 20194717115943 ()
  • 10194717115946 ()


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

Regard™ - 10194717114963

OPEN HEART A&B PACK
ROI CPS, LLC
CV01171A
Not in Commercial Distribution

  • 20194717114960 ()
  • 10194717114963 ()


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

Regard™ - 10194717113546

OPEN HEART A&B PACK
ROI CPS, LLC
CV01171
Not in Commercial Distribution

  • 20194717113543 ()
  • 10194717113546 ()


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

Regard™ - 10194717112495

CABG PACK A AND B
ROI CPS, LLC
CV00361Q
Not in Commercial Distribution

  • 20194717112492 ()
  • 10194717112495 ()


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

Medline Industries, Inc. - 10889942363131

OPEN HEART A&B PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ38366J
In Commercial Distribution

  • 10889942363131 ()
DYNJ38366J

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942360482

OPEN HEART PART B PACK
MEDLINE INDUSTRIES, INC.
DYNJ43038B
In Commercial Distribution

  • 10889942360482 ()
DYNJ43038B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10193489866612

CV A B C PPS
MEDLINE INDUSTRIES, INC.
DYNJ9773777M
In Commercial Distribution

  • 10193489866612 ()
DYNJ9773777M

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

Medline Industries, Inc. - 10193489864304

OPEN HEART B BCS PACK
MEDLINE INDUSTRIES, INC.
DYNJ45477G
In Commercial Distribution

  • 10193489864304 ()
  • 40193489864305 ()
DYNJ45477G

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

Medline Industries, Inc. - 10193489862607

A B CARDIO THORACIC PACK
MEDLINE INDUSTRIES, INC.
DYNJ61424C
In Commercial Distribution

  • 10193489862607 ()
DYNJ61424C

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

Medline Industries, Inc. - 10889942344475

OPEN HEART BASIC B PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0606274J
In Commercial Distribution

  • 10889942344475 ()
DYNJ0606274J

  • General surgical procedure kit, non-medicated, reusable
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