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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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IMMUNODIAGNOSTIC SYSTEMS LIMITED
AC-20F1
In Commercial Distribution

  • 05060169690059 ()


  • Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay
Insulin syringe U-100, 0.3cc/ml 31G 1/2" (Pack of 100) JJ CARE Insulin Syringes are disposable and meant for one time use.
Jack Jack LLC
JJ033112P-100
In Commercial Distribution

  • 05060988910079 ()
  • 25060988910073 ()
  • 15060988910076 ()


  • Insulin syringe/needle, basic
HCCA Matrix, 10 tubes
Bruker Scientific LLC
8604531
Not in Commercial Distribution

  • 10841594110013 ()
  • 00841594110016 ()
8604531

  • Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD
AccuDiag ™ dsDNA Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
Diagnostic Automation, Inc.
DACD-2553-1
In Commercial Distribution

  • 00894175000237 ()
2553-1

  • Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ IFA FTA-ABS Test System - Treponema pallidum total antibody IVD, kit, Fluorescent Immunoassay Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
Diagnostic Automation, Inc.
DACD-351010
In Commercial Distribution

  • 00894175000008 ()

  • 10x10 wells
351010

  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay
Oral Fluid Specimen Collection Tube
BRANAN MEDICAL CORPORATION
CM-190
Not in Commercial Distribution

  • 00816555020208 ()
CM-190

  • Drug-testing specimen collection kit IVD
Oral Fluid Specimen Collection Tube
AMEDITECH INC.
CM-190
Not in Commercial Distribution

  • 00816565020847 ()
CM-190

  • Drug-testing specimen collection kit IVD
IRRIGATION PUMP CEDTP100 US
MEDTRONIC, INC.
CEDTP100
In Commercial Distribution

  • 00763000709051 ()


  • Basic roller pump
GENERATOR CEDTG200 FASTR RF US
MEDTRONIC, INC.
CEDTG200
In Commercial Distribution

  • 00763000708917 ()


  • Cardiac radio-frequency ablation system generator
GENERATOR CEDTG200 FASTR RF US/CAN
MEDTRONIC, INC.
CEDTG200
In Commercial Distribution

  • 00763000687960 ()


  • Cardiac radio-frequency ablation system generator
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