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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D AND C PACK
Cardinal Health 200, LLC
SMADHDCWOF
In Commercial Distribution

  • 50195594520654 ()
  • 10195594520656 ()
SMADHDCWOF

  • Obstetrical/gynaecological surgical procedure kit, medicated
D AND C
Cardinal Health 200, LLC
SMA13DCEX2
In Commercial Distribution

  • 50195594517104 ()
  • 10195594517106 ()
SMA13DCEX2

  • Obstetrical/gynaecological surgical procedure kit, medicated
SLP D C GYN PACK
Cardinal Health 200, LLC
SMA30DNPR4
In Commercial Distribution

  • 50195594509659 ()
  • 10195594509651 ()
SMA30DNPR4

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
JFK D AND C
Cardinal Health 200, LLC
SMA11CDJK1
In Commercial Distribution

  • 50195594507396 ()
  • 10195594507398 ()
SMA11CDJK1

  • Obstetrical/gynaecological surgical procedure kit, medicated
D AND C PACK
Cardinal Health 200, LLC
SMAOCDCMT3
In Commercial Distribution

  • 50195594507044 ()
  • 10195594507046 ()
SMAOCDCMT3

  • Obstetrical/gynaecological surgical procedure kit, medicated
HEART PROGRAM BAG
CENTURION MEDICAL PRODUCTS CORPORATION
SB1335
In Commercial Distribution

  • 50653160089863 ()
  • 00653160089868 ()
SB1335

  • First aid kit, non-medicated, single-use
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-1
In Commercial Distribution

  • 00850042559529 ()
  • 10850042559526 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Fast- profile 96 well PCR plated assay and optical film for use on ABI 7500 Fast instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860127 ()
  • 05060654860080 ()
ID-CoV2-01-FPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Biorad CFX96 instrument.
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860103 ()
  • 05060654860110 ()
ID-CoV2-01-BPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Roche LightCycler 11 instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860059 ()
  • 05060654860134 ()
ID-CoV2-01-LPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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