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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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Medline Industries, Inc. - 10889942497027

CV DRAPING/BASIN A & B PACK
MEDLINE INDUSTRIES, INC.
DYNJ52874A
In Commercial Distribution

  • 10889942497027 ()
DYNJ52874A

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

Medline Industries, Inc. - 10889942472246

OPEN HEART PACK A&B SM
MEDLINE INDUSTRIES, INC.
DYNJ51911B
In Commercial Distribution

  • 10889942472246 ()
DYNJ51911B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942442928

HEART W DRAPE PACK A&B
MEDLINE INDUSTRIES, INC.
DYNJ53757
In Commercial Distribution

  • 10889942442928 ()
DYNJ53757

  • General surgical procedure kit, non-medicated, reusable

Regard™ - 10194717116073

PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932J
Not in Commercial Distribution

  • 20194717116070 ()
  • 10194717116073 ()


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

Regard™ - 10194717115922

PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932I
Not in Commercial Distribution

  • 20194717115929 ()
  • 10194717115922 ()


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

Regard™ - 10194717114253

PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932H
Not in Commercial Distribution

  • 20194717114250 ()
  • 10194717114253 ()


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

Regard™ - 10194717113102

PK CUST C CABG A & B
ROI CPS, LLC
CV00080Y
Not in Commercial Distribution

  • 20194717113109 ()
  • 10194717113102 ()


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

Regard™ - 10194717112624

PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932G
Not in Commercial Distribution

  • 20194717112621 ()
  • 10194717112624 ()


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

Regard™ - 10194717110941

PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932F
Not in Commercial Distribution

  • 20194717110948 ()
  • 10194717110941 ()


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

Regard™ - 10194717109310

PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932E
Not in Commercial Distribution

  • 20194717109317 ()
  • 10194717109310 ()


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