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
Yiwu Ori-Power Medtech Co.,Ltd.
OP30010346
In Commercial Distribution

  • 06974686053459 ()


  • First aid kit, medicated
No Description
Yiwu Ori-Power Medtech Co.,Ltd.
OP3001290
In Commercial Distribution

  • 06974686053374 ()


  • First aid kit, medicated
No Description
Yiwu Ori-Power Medtech Co.,Ltd.
OP3001153
In Commercial Distribution

  • 06974686053275 ()


  • First aid kit, medicated
No Description
Qingdao Likangyuan Medical Device Co.,Ltd.
Flat ear loop
In Commercial Distribution

  • 06972535040001 ()


  • Public face mask, single-use
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicatingrecent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Hangzhou Laihe Biotech Co.,Ltd.
303002
In Commercial Distribution

  • 06972412619405 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Partial dentures are manufactured as finished products from denture resins and other supporting materials.
Modern Dental Laboratory (DG) Co., Ltd.
012
In Commercial Distribution

  • 06972677870122 ()


  • Partial denture
Base metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from base metals.
Modern Dental Laboratory (DG) Co., Ltd.
011
In Commercial Distribution

  • 06972677870115 ()


  • Dental casting non-noble alloy
  • Custom-made dental crown, metal
Resin crown and bridge restorations are crown and bridge restorations that are manufactured as finished products from resins.
Modern Dental Laboratory (DG) Co., Ltd.
009
In Commercial Distribution

  • 06972677870092 ()


  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, polymer
  • Dental bridge, metal-polymer
  • Resin dental inlay
  • Dental veneer, professional
Noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals.
Modern Dental Laboratory (DG) Co., Ltd.
008
In Commercial Distribution

  • 06972677870085 ()


  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
No Description
Modern Dental Laboratory (DG) Co., Ltd.
007
In Commercial Distribution

  • 06972677870078 ()


  • Orthodontic retainer
  • Removable dental occlusal splint, preformed
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