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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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Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Mmqci
v.00
In Commercial Distribution

  • 00852720008442 ()
C206

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 fusion gene.
Mmqci
v.00
In Commercial Distribution

  • 00852720008336 ()
C230

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
The Access Total BhCG (5th IS) Calibrators are intended to calibrate the Access Total BhCG (5th IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
B11754
In Commercial Distribution

  • 15099590226220 ()
B11754

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
Black Nitrile Exam Gloves, Powder Free, Size Extra Large (XL)
Strong Medical Partners LLC
1405
In Commercial Distribution

  • 10850005354809 ()
  • 00850005354802 ()

  • Extra Large (XL)
  • Glove thickness is 0.12 mm or 5.0 Mils
1405

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Pro Exam Gloves, Blue, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
71045
In Commercial Distribution

  • 10850005354250 ()
  • 00850005354253 ()

  • Extra Large (XL)
  • Glove thickness is 0.10 mm or 4.0 Mils
71045

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Premium Exam Gloves, Black, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
75055
In Commercial Distribution

  • 10850005354076 ()
  • 00850005354079 ()

  • Extra Large (XL)
  • Glove thickness is 0.13 mm or 5.1 Mils
75055

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Pro Exam Gloves, Black, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
75045
In Commercial Distribution

  • 10850005354038 ()
  • 00850005354031 ()

  • Extra Large (XL)
  • Glove thickness is 0.11 mm or 4.3 Mils
75045

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Classic Exam Gloves, Black, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
75035
In Commercial Distribution

  • 10853927007969 ()
  • 00853927007962 ()

  • Extra Large (XL)
  • Glove thickness is 0.08 mm or 3.1 Mils
75035

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Gloves, Blue, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
71015
In Commercial Distribution

  • 10853927007532 ()
  • 00853927007535 ()

  • Extra Large (XL)
  • Glove thickness is 0.08 mm or 3.1 Mils
71015

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
N/A
Conformis, Inc.
RPS020220002
In Commercial Distribution

  • M572RPS0202200021 ()

  • 22mm thick on the medial side, lateral side is patient specific
RPS0202200

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
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