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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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Access TSH (3rd IS) Calibrators - 15099590671501

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

Access Total BhCG (5th IS) - 15099590744380

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.
C28645
In Commercial Distribution

  • 15099590744380 ()
C28645

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay

Neobiotech Implant System - 08809407157322

EB/IS, Ø7.0
Neobiotech. co., ltd
MP70
In Commercial Distribution

  • 08809407157322 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809407157315

EB/IS, Ø6.0
Neobiotech. co., ltd
MP60
In Commercial Distribution

  • 08809407157315 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809407157308

EB/IS, Ø5.5
Neobiotech. co., ltd
MP55
In Commercial Distribution

  • 08809407157308 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656783

IS, Ø3.5, Narrow
Neobiotech. co., ltd
SGISFPT35N
In Commercial Distribution

  • 08809815656783 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656776

IS, Ø4.0, Regular
Neobiotech. co., ltd
SGISFPT40R
In Commercial Distribution

  • 08809815656776 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656769

IS, Ø4.5, Regular
Neobiotech. co., ltd
SGISFPT45R
In Commercial Distribution

  • 08809815656769 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656752

IS, Ø5.0, Wide
Neobiotech. co., ltd
SGISFPT50W
In Commercial Distribution

  • 08809815656752 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656714

IS, Ø4.0 Regular
Neobiotech. co., ltd
NGISCT40RS
In Commercial Distribution

  • 08809815656714 ()


  • Fixture/appliance dental drill bit, reusable
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