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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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Kit Urine Collection for South Shore Hospital Only
AERO-MED, LLC
CA56125
In Commercial Distribution

  • 50885380200241 ()
  • 10885380200243 ()
CA56125

  • Urine specimen collection kit IVD
*CUSTOM* South Metro IV Admin 10 drop kit
BOUND TREE MEDICAL, LLC
8600-01354
In Commercial Distribution

  • 00812277033069 ()
8600-01354

  • Peripheral vascular intervention infusion catheter
PlasmaJet Ultra Plus Console System In-Service (South Africa)
PLASMA SURGICAL, INC
PS10-3130IS-ZA
In Commercial Distribution

  • M397PS103130ISZA0 ()
PS10-3130IS-ZA

  • Plasma surgical system
PlasmaJet V3 Plus Console System In-Service (South Africa)
PLASMA SURGICAL, INC
PS10-2130IS-ZA
In Commercial Distribution

  • M397PS102130ISZA0 ()
PS10-2130IS-ZA

  • Plasma surgical system
10M - State of South Dakota DOT BBP - Metal
Certified Safety Manufacturing, Inc.
FK412-001
In Commercial Distribution

  • 00766588120010 ()
FK412-001

  • Cardiopulmonary resuscitation mask, single-use
  • First aid kit, medicated
  • Non-rebreathing valve, single-use
C4 (Complement 4) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC635
Not in Commercial Distribution

  • 00817302020939 ()

  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 20 Milliliter
  • Total Volume: 8 Milliliter
CC635

  • Immunohistochemistry negative control (normal animal serum) IVD
C3 (Complement 3) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC634
Not in Commercial Distribution

  • 00817302020922 ()

  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 8 Milliliter
  • Total Volume: 20 Milliliter
CC634

  • Immunohistochemistry negative control (normal animal serum) IVD
APO B (Apolipoprotein B) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC633
Not in Commercial Distribution

  • 00817302020915 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 23 Milliliter
CC633

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
APO B (Apolipoprotein B) 3 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-633
In Commercial Distribution

  • 00817302020908 ()

  • Total Volume: 16 Milliliter
  • Total Volume: 46 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
AU-633

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
APO B (Apolipoprotein B) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL633
Not in Commercial Distribution

  • 00817302020892 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 23 Milliliter
BL633

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
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