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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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Kit
TOKUYAMA DENTAL CORPORATION
14912
In Commercial Distribution

  • 04548190149124 ()


  • Dentine adhesive
Bonding Agent B
TOKUYAMA DENTAL CORPORATION
14737
In Commercial Distribution

  • 04548190147373 ()


  • Dentine adhesive
Bonding Agent A
TOKUYAMA DENTAL CORPORATION
14736
In Commercial Distribution

  • 04548190147366 ()


  • Dentine adhesive
Kit
TOKUYAMA DENTAL CORPORATION
14706
In Commercial Distribution

  • 04548190147069 ()


  • Dentine adhesive
SUPER SNAP POLYSTRIPS, GN/RED
SHOFU DENTAL CORPORATION
L526
In Commercial Distribution

  • 04548162235398 ()
L526

  • Dental abrasive strip, single-use
SUPER SNAP POLYSTRIPS, BK/VT 1
SHOFU DENTAL CORPORATION
L525
In Commercial Distribution

  • 04548162235381 ()
L525

  • Dental abrasive strip, single-use
Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.
SUN MEDICAL CO.,LTD.
MC-002
Not in Commercial Distribution

  • 04560227798990 ()

  • Weight: 1.43 Kilogram
KS51US

  • Denture reliner, hard
Lumipulse G B-Amyloid Controls (Plasma)-N
FUJIREBIO INC.
235485
Not in Commercial Distribution

  • 04987270235485 ()

  • 4 bottles per unit; 1.0mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
Lumipulse G B-Amyloid 1-42-N Plasma IRC
FUJIREBIO INC.
235447
In Commercial Distribution

  • 04987270235447 ()

  • 42 Tests per Kit


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-60601
Not in Commercial Distribution

  • 00856626006205 ()
999-60601

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-60701
Not in Commercial Distribution

  • 00856626006120 ()
995-60701

  • Des-gamma-carboxyprothrombin (DCP) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-06101
Not in Commercial Distribution

  • 00856626006106 ()
995-06101

  • Microalbumin IVD, calibrator
No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-500ML
In Commercial Distribution

  • 00857515006160 ()

  • Total Volume: 500 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-500ML
In Commercial Distribution

  • 00857515006153 ()

  • Total Volume: 500 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang C 70ML Frozen Supplement
FUJIFILM IRVINE SCIENTIFIC, INC.
C108-70ML
In Commercial Distribution

  • 00857515006122 ()

  • Total Volume: 70 Milliliter
C108

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang C 14ML Frozen Supplement
FUJIFILM IRVINE SCIENTIFIC, INC.
C106-14ML
In Commercial Distribution

  • 00857515006115 ()

  • Total Volume: 14 Milliliter
C106

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
CHANG Medium® D with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
99404-500mL
Not in Commercial Distribution

  • 00857515006030 ()

  • Total Volume: 500 Milliliter
99404

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
S8377 Cleaning MET II Solution membrane bottle , 6*100mL for ABL8XX
Radiometer Medical ApS
944-136
In Commercial Distribution

  • 15700699441369 ()
  • 05700699441362 ()
944-136

  • Wash/cleaning solution IVD, automated/semi-automated system
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, USA
Radiometer Medical ApS
944-135
In Commercial Distribution

  • 15700699441352 ()
  • 05700699441355 ()
944-135

  • Multiple blood gas analyte IVD, calibrator
S1837 Crea Calibration Solution 2, membrane bottle, 6x140 mL, for ABL8XX
Radiometer Medical ApS
944-134
In Commercial Distribution

  • 15700699441345 ()
  • 05700699441348 ()
944-134

  • Multiple blood gas analyte IVD, calibrator
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, JAP/ROW
Radiometer Medical ApS
944-133
In Commercial Distribution

  • 15700699441338 ()
  • 05700699441331 ()
944-133

  • Multiple blood gas analyte IVD, calibrator
S7375 Cleaning Solution 175mL for ABL7XX
Radiometer Medical ApS
944-123
Not in Commercial Distribution

  • 05700699441232 ()
944-123

  • Wash/cleaning solution IVD, automated/semi-automated system
S7865 AutoCheck 6+, level 4 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-097
In Commercial Distribution

  • 55700699440971 ()
  • 05700699440976 ()
944-097

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7855 AutoCheck 6+, level 3 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-096
In Commercial Distribution

  • 55700699440964 ()
  • 05700699440969 ()
944-096

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7845 AutoCheck 6+, level 2 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-095
In Commercial Distribution

  • 55700699440957 ()
  • 05700699440952 ()
944-095

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7835 AutoCheck 6+, level 1 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-094
In Commercial Distribution

  • 55700699440940 ()
  • 05700699440945 ()
944-094

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
D8088+D8089 Crea membrane box A+B, with 2xA and 2xB membrane units, for ABL8XX
Radiometer Medical ApS
942-073
In Commercial Distribution

  • 05700699420732 ()
942-073

  • Creatinine IVD, reagent
D7077 Lac membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-066
In Commercial Distribution

  • 05700699420664 ()
  • 55700699420669 ()
942-066

  • Lactate electrode IVD
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
APPLIED BIOCODE, INC.
01
In Commercial Distribution

  • 00851034007073 ()
63-R0001

  • Multiple-type respiratory pathogen nucleic acid IVD, control
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007011 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
UF ll CALIBRATOR
SYSMEX CORPORATION
06404310
In Commercial Distribution

  • 04987562408535 ()
  • 84987562408531 ()


  • Urine sediment IVD, calibrator
UF-CONTROL contains control particles for use in quality control measurement procedure of the Sysmex Fully Automated Urine Particle Analyzers and the Sysmex Fully Automated Urine Particle Digital Imaging Device.
SYSMEX CORPORATION
06404115
In Commercial Distribution

  • 04987562408528 ()

  • Total Volume: 47 Milliliter


  • Buffered sample diluent IVD
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-76491
In Commercial Distribution

  • 04987481164642 ()
997-76491

  • Non-esterified fatty acid IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-06101
In Commercial Distribution

995-06101

  • Microalbumin IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-61201
In Commercial Distribution

999-61201

  • Des-gamma-carboxyprothrombin (DCP) IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-60901
In Commercial Distribution

997-60901

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-60701
In Commercial Distribution

995-60701

  • Des-gamma-carboxyprothrombin (DCP) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-40801
In Commercial Distribution

995-40801

  • Total complement activity (CH50) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-60601
In Commercial Distribution

999-60601

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, reagent
Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
73806
In Commercial Distribution

  • 04987486738060 ()


  • Multiple urine analyte IVD, control
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