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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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HEATmarker® Time-Temperature Indicators: F6 - 00852282007013

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 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: F3 - 00852282007006

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 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical

Personalized PseudoPatient™ PV - 00860001523218

Personalized PseudoPatient™ PV FL
RTSAFE, INC.
PFL-02PV
In Commercial Distribution

  • 00860001523218 ()
PFL-02PV

  • Custom-made organ/bone anatomy model

Personalized PseudoPatient™ PV - 00860001523201

Personalized PseudoPatient™ PV IC
RTSAFE, INC.
PIC-02PV
In Commercial Distribution

  • 00860001523201 ()
PIC-02PV

  • Custom-made organ/bone anatomy model

Bandtite Band Cement - 00190746007873

BANDTITE GLASS IONOMER POWDER 100 GMS
AMERICAN ORTHODONTICS CORPORATION
001-972
In Commercial Distribution

  • 00190746007873 ()
001-972

  • Orthodontic bracket adhesive

Bandtite Band Cement - 00190746007866

BANDTITE GLASS IONOMER LIQUID 60 CC
AMERICAN ORTHODONTICS CORPORATION
001-971
In Commercial Distribution

  • 00190746007866 ()
001-971

  • Orthodontic bracket adhesive

Bandtite Band Cement - 00190746007859

BANDTITE GLASS IONOMER CEMENT MINI KIT
AMERICAN ORTHODONTICS CORPORATION
001-970M
Not in Commercial Distribution

  • 00190746007859 ()
001-970M

  • Orthodontic bracket adhesive

Bandtite Band Cement - 00190746007842

BANDTITE GLASS IONOMER CEMENT KIT
AMERICAN ORTHODONTICS CORPORATION
001-970
In Commercial Distribution

  • 00190746007842 ()
001-970

  • Orthodontic bracket adhesive

Silan-IT - 03760260223119

Cross-linking agent containing silan agent to improve adhesion
ITENA CLINICAL
SILAN-IT
In Commercial Distribution

  • 03760260223119 ()


  • Dental prosthesis priming agent

Ipana 5% Sodium Fluoride Varnish - Melon - 00060705405333

No Description
MAXILL, INC.
40533
In Commercial Distribution

  • 00060705405333 ()
  • 90060705405336 ()


  • Dental cavity varnish
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