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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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Alternate name : Cytokeratin 5/6 (CK 5/6)
BIOCARE MEDICAL LLC
CM105B
In Commercial Distribution

  • 00847627006158 ()


  • Cytokeratin IVD, kit, enzyme immunohistochemistry
Alternate name : Cytokeratin 5/6 (CK 5/6)
BIOCARE MEDICAL LLC
CM105A
In Commercial Distribution

  • 00847627006141 ()


  • Cytokeratin IVD, antibody
DrugSmart Cup 5, AMP/COC/OPI/OXY/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60565D
In Commercial Distribution

  • 00812203030124 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Roche Diagnostics GmbH
08133859190
In Commercial Distribution

  • 07613336143162 ()
08133859190

  • Collagen type I cross-linked C-telopeptide IVD, control
CryoPRO™-5 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0442
In Commercial Distribution

  • B039SGI04421 ()
  • B039SGI04420 ()
  • B039SGI04429 ()


  • Blood cell freeze/thaw system
The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. For information on the use of Omnitrope Pen 5, see: http://www.omnitrope.com/getting-started/injection-training/
Sandoz GmbH
49036229
Not in Commercial Distribution

  • 49002269218553 ()
  • 59002269207349 ()


  • Empty self-injector, mechanical
Distal Access Catheter
Stryker Corporation
M003IC0581150
In Commercial Distribution

  • 07613327012019 ()

  • Length: 115.0 Centimeter
  • Lumen/Inner Diameter: 0.058 Inch
IC058115

  • Vascular guide-catheter, single-use
Distal Access Catheter
Stryker Corporation
M003IC0581320
In Commercial Distribution

  • 07613327011999 ()

  • Lumen/Inner Diameter: 0.058 Inch
  • Length: 132.0 Centimeter
IC058132

  • Vascular guide-catheter, single-use
No Description
BIOGENEX LABORATORIES
NU892-UC
In Commercial Distribution

  • 00810119679031 ()

  • Total Volume: 1 Milliliter
NU892-UC

  • Multiple squamous cell carcinoma-associated marker IVD, antibody
No Description
ACCUTRON, INC.
34016
In Commercial Distribution

  • 00813830021813 ()
34016

  • Anaesthesia workstation gas scavenger
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