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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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First Aid Only - 00738743710800

First aid kit refill module. Contains first aid supplies for eye injuries.
Acme United Corporation
71-080
In Commercial Distribution

  • 00738743710800 ()
71-080

  • First aid kit, medicated

First Aid Only - 00738743710305

First aid kit refill. Module with first aid supplies for minor wounds.
Acme United Corporation
71-030
In Commercial Distribution

  • 00738743710305 ()
71-030

  • First aid kit, medicated

Genedrive(R) 96 SARS CoV2 kit - 05060654860103

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)

Osteon Medical - D102BAR0

The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
IMPLANT SOLUTIONS PTY LTD
1
In Commercial Distribution

  • D102BAR0 ()


  • Dental implant suprastructure, permanent, custom-made
  • Dental implant suprastructure, temporary, custom-made

First Aid Only - 00073577901032

First Aid Kit refill containing first aid supplies for treatment of minor injuries
Acme United Corporation
90103
In Commercial Distribution

  • 00073577901032 ()
90103

  • First aid kit, medicated

First Aid Only - 00073577901643

First Aid Kit refill containing first aid supplies for first aid kit 60003
Acme United Corporation
90164
In Commercial Distribution

  • 00073577901643 ()
90164

  • First aid kit, medicated

First Aid Only - 00738743064200

First aid kit for vehicles in a metal case containing first aid supplies
Acme United Corporation
6420
In Commercial Distribution

  • 00738743064200 ()
6420

  • First aid kit, medicated

Genedrive(R)96 SARS-CoV2-kit - 05060654860059

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)

Genedrive(R)96 SARS-CoV2-kit - 05060654860127

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)

Trinity Biotech - 05391516748049

Monkey Kidney 8 Well Slides, 12 each pack
MARDX DIAGNOSTICS, INC.
10-5808
In Commercial Distribution

  • 05391516748049 ()
10-5808

  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay
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