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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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LOSPA IS Spinal System - 08806373870095

ACIF TRIAL 12 X 14 X 06
Corentec Co., Ltd
SI.C10.0012
In Commercial Distribution

  • 08806373870095 ()


  • Spinal implant trial

LOSPA IS Spinal System - 08806373870088

ACIF TRIAL 12 X 14 X 05
Corentec Co., Ltd
SI.C10.0011
In Commercial Distribution

  • 08806373870088 ()


  • Spinal implant trial

LOSPA IS Spinal System - 08806373870002

ACIF HOLDER
Corentec Co., Ltd
SI.C10.0001
In Commercial Distribution

  • 08806373870002 ()


  • Surgical implant/trial-implant/sizer holder, reusable

Access TSH (3rd IS) - 15099590671495

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results.
Beckman Coulter, Inc.
B63284
In Commercial Distribution

  • 15099590671495 ()
B63284

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Access TSH (3rd IS) - 15099590744373

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results.
Beckman Coulter, Inc.
C28643
In Commercial Distribution

  • 15099590744373 ()
C28643

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IS 3800 I/O 3D SCANNER - 00693856000043

IS 3800
Dental Imaging Technologies Corporation
5943725
In Commercial Distribution

  • 00693856000043 ()
5943725

  • Intraoral optical scanning system

Neobiotech Implant System - 08809815655830

IS, Ø5.5
Neobiotech. co., ltd
PTAP55FS
In Commercial Distribution

  • 08809815655830 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815655816

IS, Ø4.0
Neobiotech. co., ltd
PTAP40FL
In Commercial Distribution

  • 08809815655816 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815655809

IS, Ø4.5
Neobiotech. co., ltd
PTAP45FL
In Commercial Distribution

  • 08809815655809 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815655793

IS, Ø5.0
Neobiotech. co., ltd
PTAP50FL
In Commercial Distribution

  • 08809815655793 ()


  • Fixture/appliance dental drill bit, reusable
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