SEARCH RESULTS FOR: AT(187 results)

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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 Class Implantable

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GenBody COVID-19 Ag Home Test - 08800076700598

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-25
In Commercial Distribution

  • 08800076700765 ()
  • 08800076700598 ()
COVAGHT2-U-25

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

GenBody COVID-19 Ag Home Test - 08800076700222

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-2
In Commercial Distribution

  • 08800076700741 ()
  • 08800076700222 ()
COVAGHT2-U-02

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

REFLECT - 00193982313470

REFLECT 5.0mm Cord with Collet, 350mm
GLOBUS MEDICAL, INC.
1244.1351S
In Commercial Distribution

  • 00193982313470 ()


  • Trans-facet-screw internal spinal fixation system, sterile

REFLECT - 00193982313463

REFLECT 4.0mm Cord with Collet, 350mm
GLOBUS MEDICAL, INC.
1244.1350S
In Commercial Distribution

  • 00193982313463 ()


  • Trans-facet-screw internal spinal fixation system, sterile

REFLECT - 00193982313456

REFLECT 5.0mm Cord with Collet, 250mm
GLOBUS MEDICAL, INC.
1244.1251S
In Commercial Distribution

  • 00193982313456 ()


  • Trans-facet-screw internal spinal fixation system, sterile

REFLECT - 00193982313449

REFLECT 4.0mm Cord with Collet, 250mm
GLOBUS MEDICAL, INC.
1244.1250S
In Commercial Distribution

  • 00193982313449 ()


  • Trans-facet-screw internal spinal fixation system, sterile

REFLECT - 00193982313340

Dual Staple, Small, Caudal
GLOBUS MEDICAL, INC.
1244.0210
In Commercial Distribution

  • 00193982313340 ()


  • Trans-facet-screw internal spinal fixation system, sterile

REFLECT - 00193982313265

Dual Staple, Small, Rostral
GLOBUS MEDICAL, INC.
1244.0200
In Commercial Distribution

  • 00193982313265 ()


  • Trans-facet-screw internal spinal fixation system, sterile

REFLECT - 00193982313081

REFLECT Locking Cap
GLOBUS MEDICAL, INC.
1244.0000
In Commercial Distribution

  • 00193982313081 ()


  • Trans-facet-screw internal spinal fixation system, sterile

REFLECT - 00193982310806

REFLECT HA Monoaxial Screw, 7.5x55mm
GLOBUS MEDICAL, INC.
5244.0756S
In Commercial Distribution

  • 00193982310806 ()


  • Trans-facet-screw internal spinal fixation system, sterile
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