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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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ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, Tape Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Double-needle Flat Felled Chainstitch Construction
STANDARD TEXTILE CO., INC.
75614905
In Commercial Distribution

  • 00634916795493 ()


  • Surgical gown, reusable
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 22.5°C.
Temptime Corporation
CT9
In Commercial Distribution

  • 00852282007105 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 22.5°C.
Temptime Corporation
CT6
In Commercial Distribution

  • 00852282007099 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 121 days at 22.5°C.
Temptime Corporation
CT4
In Commercial Distribution

  • 00852282007082 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 22.5°C.
Temptime Corporation
CT3
In Commercial Distribution

  • 00852282007075 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 60 days at 22.5°C.
Temptime Corporation
CT2
In Commercial Distribution

  • 00852282007068 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 5°C.
Temptime Corporation
F36
In Commercial Distribution

  • 00852282007051 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 5°C.
Temptime Corporation
F24
In Commercial Distribution

  • 00852282007044 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.
Temptime Corporation
F12
In Commercial Distribution

  • 00852282007037 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 5°C.
Temptime Corporation
F9
In Commercial Distribution

  • 00852282007020 ()


  • Medical product temperature point indicator, thermochemical
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