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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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The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.
Beckman Coulter, Inc.
A85264
In Commercial Distribution

  • 15099590226213 ()
A85264

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
The Access TSH (3rd IS) Calibrators are intended to calibrate the Access TSH (3rd IS) assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
B63285
In Commercial Distribution

  • 15099590671501 ()
B63285

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
FineCross M3 Coronary Micro-Guide Catheter
TERUMO CORPORATION
M3-1430
In Commercial Distribution

  • 54987892058870 ()
  • 04987892058875 ()

  • Length: 130 Centimeter
  • Outer Diameter: 0.61 Millimeter
  • Outer Diameter: 0.84 Millimeter
  • Clinically Relevant Size 1 is relative to catheter distal part. Clinically Relevant Size 2 is relative to catheter proximal part.
NC*A853B

  • Vascular guide-catheter, single-use
FineCross M3 Coronary Micro-Guide Catheter
TERUMO CORPORATION
M3-1450
In Commercial Distribution

  • 54987892058856 ()
  • 04987892058851 ()

  • Clinically Relevant Size 1 is relative to catheter distal part. Clinically Relevant Size 2 is relative to catheter proximal part.
  • Outer Diameter: 0.84 Millimeter
  • Outer Diameter: 0.61 Millimeter
  • Length: 150 Centimeter
NC*A855B

  • Vascular guide-catheter, single-use
IS Liquid 100ml
KURARAY NORITAKE DENTAL INC.
126-0122KA
In Commercial Distribution

  • EKUR1260122KA0 ()


  • Dental appliance fabrication material, ceramic
IS Liquid 10ml
KURARAY NORITAKE DENTAL INC.
126-0111KA
In Commercial Distribution

  • EKUR1260111KA0 ()


  • Dental appliance fabrication material, ceramic
3G IS Fluoro
KURARAY NORITAKE DENTAL INC.
109-0511KA
In Commercial Distribution

  • EKUR1090511KA0 ()


  • Dental appliance fabrication material, ceramic
3G IS Bright
KURARAY NORITAKE DENTAL INC.
109-0501KA
In Commercial Distribution

  • EKUR1090501KA0 ()


  • Dental appliance fabrication material, ceramic
3G IS B+
KURARAY NORITAKE DENTAL INC.
109-0491KA
In Commercial Distribution

  • EKUR1090491KA0 ()


  • Dental appliance fabrication material, ceramic
3G IS A+
KURARAY NORITAKE DENTAL INC.
109-0481KA
In Commercial Distribution

  • EKUR1090481KA0 ()


  • Dental appliance fabrication material, ceramic
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