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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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Isolation Gown with Knit Cuffs - Blue
Plastcare USA
RIT-G30B
In Commercial Distribution

  • D915RITG30B2 ()
  • D915RITG30B1 ()
  • D915RITG30B0 ()


  • Professional examination gown, single-use
(7 1/2" x 14") Sterilization Pouches
Plastcare USA
RIT-7514
In Commercial Distribution

  • D915RIT75141 ()
  • D915RIT75142 ()
  • D915RIT75140 ()


  • Sterilization packaging, single-use
Dental Impression Bite Tray Sideless (White)
Plastcare USA
RIT-7315
In Commercial Distribution

  • D915RIT73152 ()
  • D915RIT73151 ()
  • D915RIT73150 ()


  • Dental impression tray, single-use
Dental Impression Bite Tray Quadrant (Yellow)
Plastcare USA
RIT-7313
In Commercial Distribution

  • D915RIT73132 ()
  • D915RIT73131 ()
  • D915RIT73130 ()


  • Dental impression tray, single-use
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
No Description
MAXILL, INC.
6070560184
In Commercial Distribution

  • D89260705601842 ()
  • D89260705601841 ()
  • D89260705601840 ()


  • Sterilization packaging, single-use
No Description
MAXILL, INC.
6070560149
In Commercial Distribution

  • D89260705601492 ()
  • D89260705601491 ()
  • D89260705601490 ()


  • Sterilization packaging, single-use
No Description
MAXILL, INC.
6070560148
In Commercial Distribution

  • D89260705601482 ()
  • D89260705601481 ()
  • D89260705601480 ()


  • Sterilization packaging, single-use
No Description
MAXILL, INC.
6070560147
In Commercial Distribution

  • D89260705601472 ()
  • D89260705601471 ()
  • D89260705601470 ()


  • Sterilization packaging, single-use
No Description
MAXILL, INC.
6070560142
In Commercial Distribution

  • D89260705601422 ()
  • D89260705601421 ()
  • D89260705601420 ()


  • Sterilization packaging, single-use
No Description
MAXILL, INC.
6070560059
In Commercial Distribution

  • D89260705600591 ()
  • D89260705600590 ()


  • Chemical/physical sterilization process indicator
No Description
MAXILL, INC.
6070560058
In Commercial Distribution

  • D89260705600581 ()
  • D89260705600580 ()


  • Chemical/physical sterilization process indicator
No Description
MAXILL, INC.
6070560057
In Commercial Distribution

  • D89260705600571 ()
  • D89260705600570 ()


  • Chemical/physical sterilization process indicator
No Description
MAXILL, INC.
6070560047
In Commercial Distribution

  • D89260705600471 ()
  • D89260705600470 ()


  • Sterilization packaging, single-use
No Description
MAXILL, INC.
6070560046
In Commercial Distribution

  • D89260705600461 ()
  • D89260705600460 ()


  • Sterilization packaging, single-use
No Description
MAXILL, INC.
6070560045
In Commercial Distribution

  • D89260705600451 ()
  • D89260705600450 ()


  • Sterilization packaging, single-use
No Description
MAXILL, INC.
6070553484
In Commercial Distribution

  • D89260705534842 ()
  • D89260705534841 ()
  • D89260705534840 ()


  • Isolation gown, reusable
No Description
MAXILL, INC.
6070553483
In Commercial Distribution

  • D89260705534832 ()
  • D89260705534831 ()
  • D89260705534830 ()


  • Isolation gown, reusable
No Description
MAXILL, INC.
6070553482
In Commercial Distribution

  • D89260705534822 ()
  • D89260705534821 ()
  • D89260705534820 ()


  • Isolation gown, reusable
No Description
MAXILL, INC.
6070553481
In Commercial Distribution

  • D89260705534812 ()
  • D89260705534811 ()
  • D89260705534810 ()


  • Isolation gown, reusable
No Description
MAXILL, INC.
6070553480
In Commercial Distribution

  • D89260705534802 ()
  • D89260705534801 ()
  • D89260705534800 ()


  • Isolation gown, reusable
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