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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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No Description
DIAGNOSTICA STAGO
00594
In Commercial Distribution

  • 03607450005943 ()


  • Lupus anticoagulant marker IVD, kit, clotting
Coil for S-scan - G-scan Brio
ESAOTE SPA
130000014
In Commercial Distribution

  • 08056304452702 ()


  • MRI system coil, radio-frequency
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-2010-20
Not in Commercial Distribution

  • 04049016072423 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-2005-20
Not in Commercial Distribution

  • 04049016040279 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-1010-20
Not in Commercial Distribution

  • 04049016040262 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-1005-20
Not in Commercial Distribution

  • 04049016040255 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-1003-20
Not in Commercial Distribution

  • 04049016040248 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Module
NOVASTEP
ACC1001P0010
Not in Commercial Distribution

  • 03700879505879 ()
ACC1001P0010

  • Device sterilization/disinfection container, reusable
BioHPP for2press - 20 g 5 pellets ds2 of 4 g each dentin-shade 2 5 Pieces
bredent GmbH & Co. KG
540F2P26
In Commercial Distribution

  • EBRE540F2P269 ()
  • EBRE540F2P260 ()
540F2P26

  • Dental bridge, polymer
4-hour ID of Enterobacteriaceae. API®strips give accurate ID based on extensive databases and are standardized, easy-to-use test systems.
BIOMERIEUX SA
RAPID 20 E™
In Commercial Distribution

  • 03573026048617 ()
  • 03573026588526 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
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