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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,D AND C, LW
Cardinal Health 200, LLC
PB42DCTM1
In Commercial Distribution

  • 50888439987544 ()
  • 10888439987546 ()
PB42DCTM1

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
D AND C PACK
Cardinal Health 200, LLC
SMA13DCNTM
In Commercial Distribution

  • 50888439985403 ()
  • 10888439985405 ()
SMA13DCNTM

  • Obstetrical/gynaecological surgical procedure kit, medicated
SLING PACK
Cardinal Health 200, LLC
SMACGDCUSF
In Commercial Distribution

  • 50888439981597 ()
  • 10888439981599 ()
SMACGDCUSF

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
D AND C PACK
Cardinal Health 200, LLC
SMA29DCPCE
In Commercial Distribution

  • 50888439981276 ()
  • 10888439981278 ()
SMA29DCPCE

  • Obstetrical/gynaecological surgical procedure kit, medicated
D C PACK
Cardinal Health 200, LLC
SMA18DCGHK
In Commercial Distribution

  • 50888439991350 ()
  • 10888439991352 ()
SMA18DCGHK

  • Obstetrical/gynaecological surgical procedure kit, medicated
D AND C PACK
Cardinal Health 200, LLC
SMA3BDCUSY
In Commercial Distribution

  • 50888439989241 ()
  • 10888439989243 ()
SMA3BDCUSY

  • Obstetrical/gynaecological surgical procedure kit, medicated
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)
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6502
In Commercial Distribution

  • 05060169695962 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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