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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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ABBOTT PRISM Pipette Tips
ABBOTT LABORATORIES
5A07-10
Not in Commercial Distribution

  • 00380740007911 ()
  • 00380740138325 ()
05A0710

  • Chemiluminescent immunoassay analyser IVD
ABBOTT PRISM Reaction Trays
ABBOTT LABORATORIES
5A07-01
Not in Commercial Distribution

  • 00380740007904 ()
  • 00380740132361 ()
05A0701

  • Chemiluminescent immunoassay analyser IVD
No Description
Modern Dental Laboratory (DG) Co., Ltd.
316
In Commercial Distribution

  • 06972677873178 ()
  • 06972677873161 ()


  • Partial denture
  • Complete upper denture
  • Complete lower denture
  • Removable dental occlusal splint, preformed
  • Orthodontic retainer
No Description
Modern Dental Laboratory (DG) Co., Ltd.
124
In Commercial Distribution

  • 06972677871259 ()
  • 06972677871242 ()


  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Dental veneer, professional
  • Removable dental occlusal splint, preformed
  • Orthodontic retainer
No Description
Modern Dental Laboratory (DG) Co., Ltd.
334
In Commercial Distribution

  • 06972677873352 ()
  • 06972677873345 ()


  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
  • Removable dental occlusal splint, preformed
  • Orthodontic retainer
D AND C PACK
Cardinal Health 200, LLC
SMAVADCGMB
In Commercial Distribution

  • 50195594963505 ()
  • 10195594963507 ()
SMAVADCGMB

  • Cardiothoracic surgical procedure kit, medicated, single-use
OSOM Flu SARS-CoV-2 Combo Control Kit
SEKISUI DIAGNOSTICS, LLC
1079
In Commercial Distribution

  • 00742860000072 ()
  • 50742860100678 ()
  • 10742860000079 ()


  • Multiple-genus respiratory virus antigen IVD, control
Alinity m Resp-4-Plex CTRL Kit
ABBOTT MOLECULAR INC.
09N79-086
In Commercial Distribution

  • 00884999049406 ()
09N79-086

  • Multiple-genus respiratory virus nucleic acid IVD, control
Sofia®2 Flu + SARS Antigen FIA
QUIDEL CORPORATION
20377
In Commercial Distribution

  • 30014613339229 ()
20377

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
REAL i-Series
PENUMBRA, INC.
RLE1-A
In Commercial Distribution

  • 00815948024229 ()


  • Mental health/function therapeutic software, virtual reality
  • Mindfulness/behavioural therapy software, non-clinician-consultative
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