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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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Dental Impression Bite Tray Full Arch (Pink)
Plastcare USA
RIT-7311
In Commercial Distribution

  • D915RIT73112 ()
  • D915RIT73111 ()
  • D915RIT73110 ()


  • Dental impression tray, single-use
5oz Disposable Plastic Dental Cup Lavender
Plastcare USA
RIT-5030
In Commercial Distribution

  • D915RIT50302 ()
  • D915RIT50301 ()
  • D915RIT50300 ()


  • Medicine cup, single-use
5oz Disposable Plastic Dental Cup Pink
Plastcare USA
RIT-5015
In Commercial Distribution

  • D915RIT50152 ()
  • D915RIT50151 ()
  • D915RIT50150 ()


  • Medicine cup, single-use
Procedure Mask
AMD Medicom Inc
430HVB
In Commercial Distribution

  • D903430HVB2 ()
  • D903430HVB1 ()
  • D903430HVB0 ()
430HVB

  • Surgical/medical face mask, single-use
Procedure Mask
AMD Medicom Inc
420LFW
In Commercial Distribution

  • D903420LFW2 ()
  • D903420LFW1 ()
  • D903420LFW0 ()
420LFW

  • Surgical/medical face mask, single-use
Procedure Mask
AMD Medicom Inc
420LFP
In Commercial Distribution

  • D903420LFP2 ()
  • D903420LFP1 ()
  • D903420LFP0 ()
420LFP

  • Surgical/medical face mask, single-use
Procedure Mask
AMD Medicom Inc
410MB
In Commercial Distribution

  • D903410MB2 ()
  • D903410MB1 ()
  • D903410MB0 ()
410MB

  • Surgical/medical face mask, single-use
Package includes Rex Mallet Console and the following individually packaged accessories: Rex Mallet Handpiece, Rex Mallet Foot Pedal, P. Striker / Remover, Wrench (not a medical device), and Rex Mallet Handpiece Holder (not a medical device)
Rex Implants, Inc.
Rex Mallet
In Commercial Distribution

  • D894040001310 ()
  • D894052000021010 ()
04000131

  • Orthopaedic implant impactor, reusable
No Description
MAXILL, INC.
6070581415
In Commercial Distribution

  • D89260705814151 ()
  • D89260705814150 ()


  • Infrared patient thermometer, ear/skin
No Description
MAXILL, INC.
6070560186
In Commercial Distribution

  • D89260705601862 ()
  • D89260705601861 ()
  • D89260705601860 ()


  • Sterilization packaging, single-use
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