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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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Face Shields
Premium Plus International Limited
1145-BLUE
In Commercial Distribution

  • D8381145BLUE8 ()
  • D8381145BLUE4 ()


  • Face splash shield, single-use
Disposable Barrier Sleeves
Premium Plus International Limited
114
In Commercial Distribution

  • D8381148 ()
  • D8381142 ()
  • D8381140 ()


  • Instrument/equipment drape, single-use, non-sterile
cotton roll dispenser
Premium Plus International Limited
1140-WHITE
In Commercial Distribution

  • D8381140WHITE8 ()
  • D8381140WHITE2 ()


  • Surgical instrument interim-placement holder, reusable
cotton roll dispenser
Premium Plus International Limited
1140-BLUE
In Commercial Distribution

  • D8381140BLUE8 ()
  • D8381140BLUE2 ()


  • Surgical instrument interim-placement holder, reusable
cotton roll dispenser
Premium Plus International Limited
1140-BEIGE
In Commercial Distribution

  • D8381140BEIGE8 ()
  • D8381140BEIGE2 ()


  • Surgical instrument interim-placement holder, reusable
Disposable Barrier Sleeves
Premium Plus International Limited
113
In Commercial Distribution

  • D8381138 ()
  • D8381132 ()
  • D8381130 ()


  • Instrument/equipment drape, single-use, non-sterile
Disposable Barrier Sleeves
Premium Plus International Limited
112
In Commercial Distribution

  • D8381128 ()
  • D8381122 ()
  • D8381120 ()


  • Instrument/equipment drape, single-use, non-sterile
Disposable Barrier Sleeves
Premium Plus International Limited
111
In Commercial Distribution

  • D8381118 ()
  • D8381112 ()
  • D8381110 ()


  • Instrument/equipment drape, single-use, non-sterile
Disposable Barrier Sleeves
Premium Plus International Limited
109
In Commercial Distribution

  • D8381098 ()
  • D8381092 ()
  • D8381090 ()


  • Instrument/equipment drape, single-use, non-sterile
Disposable Barrier Sleeves
Premium Plus International Limited
108
In Commercial Distribution

  • D8381088 ()
  • D8381082 ()
  • D8381080 ()


  • Instrument/equipment drape, single-use, non-sterile
Disposable Barrier Sleeves
Premium Plus International Limited
107
In Commercial Distribution

  • D8381078 ()
  • D8381072 ()
  • D8381070 ()


  • Instrument/equipment drape, single-use, non-sterile
Disposable Barrier Sleeves
Premium Plus International Limited
105
In Commercial Distribution

  • D8381058 ()
  • D8381052 ()
  • D8381050 ()


  • Instrument/equipment drape, single-use, non-sterile
Disposable Barrier Sleeves
Premium Plus International Limited
102
In Commercial Distribution

  • D8381028 ()
  • D8381022 ()
  • D8381020 ()


  • Instrument/equipment drape, single-use, non-sterile
Disposable Barrier Sleeves
Premium Plus International Limited
101
In Commercial Distribution

  • D8381018 ()
  • D8381012 ()
  • D8381010 ()


  • Instrument/equipment drape, single-use, non-sterile
Napkin Holders
Premium Plus International Limited
090-YELLOW
In Commercial Distribution

  • D838090YELLOW8 ()
  • D838090YELLOW4 ()


  • Towel clamp, reusable
Napkin Holders
Premium Plus International Limited
090-RED
In Commercial Distribution

  • D838090RED8 ()
  • D838090RED4 ()


  • Towel clamp, reusable
Napkin Holders
Premium Plus International Limited
090-LBLUE
In Commercial Distribution

  • D838090LBLUE8 ()
  • D838090LBLUE4 ()


  • Towel clamp, reusable
Syringe Tip Shields
Premium Plus International Limited
015
In Commercial Distribution

  • D8380158 ()
  • D8380152 ()
  • D8380150 ()


  • Dental delivery system irrigation handpiece
Digital Sensor Sheaths for Suni, Lightyear #2
PLASDENT CORPORATION
XS-SUNI-2
In Commercial Distribution

  • D832XSSUNI22 ()
  • D832XSSUNI21 ()
  • D832XSSUNI20 ()
XS-SUNI-2

  • Medical equipment drape, single-use
Digital Sensor Sheaths for Schick #2
PLASDENT CORPORATION
XS-SHICK-2
In Commercial Distribution

  • D832XSSHICK22 ()
  • D832XSSHICK21 ()
  • D832XSSHICK20 ()
XS-SHICK-2

  • Medical equipment drape, single-use
Digital Sensor Sheaths for Regam #2
PLASDENT CORPORATION
XS-REGAM-2
In Commercial Distribution

  • D832XSREGAM22 ()
  • D832XSREGAM21 ()
  • D832XSREGAM20 ()
XS-REGAM-2

  • Medical equipment drape, single-use
Digital Sensor Sheaths for Gendex, XDR #1
PLASDENT CORPORATION
XS-GXDR-1
In Commercial Distribution

  • D832XSGXDR12 ()
  • D832XSGXDR11 ()
  • D832XSGXDR10 ()
XS-GXDR-1

  • Medical equipment drape, single-use
Digital Sensor Sheaths for Cygnus Ray #1
PLASDENT CORPORATION
XS-CYGNUS-1
In Commercial Distribution

  • D832XSCYGNUS12 ()
  • D832XSCYGNUS11 ()
  • D832XSCYGNUS10 ()
XS-CYGNUS-1

  • Medical equipment drape, single-use
Digital Sensor Sheaths for Kodak 6100 #1
PLASDENT CORPORATION
XS-6100-1
In Commercial Distribution

  • D832XS610012 ()
  • D832XS610011 ()
  • D832XS610010 ()
XS-6100-1

  • Medical equipment drape, single-use
Universal Film Mounts, Box with White Space
PLASDENT CORPORATION
VP-1000
In Commercial Distribution

  • D832VP10002 ()
  • D832VP10001 ()
  • D832VP10000 ()
VP-1000

  • X-ray film cassette holder
Clear 3 Way Syringe Tips, Sani-Tip Compatible
PLASDENT CORPORATION
TST-SNTP
In Commercial Distribution

  • D832TSTSNTP0 ()
  • D832TSTSNTP1 ()
  • D832TSTSNTPB1 ()
TST-SNTP

  • Dental material injection cannula, single-use
Touch Screen Barrier Film, Laptop, 16" X 10"
PLASDENT CORPORATION
THS1610
In Commercial Distribution

  • D832THS16102 ()
  • D832THS16101 ()
  • D832THS16100 ()
THS1610

  • Medical equipment drape, single-use
Touch Screen Barrier Film, Tablet, 11" X 8 1/2"
PLASDENT CORPORATION
THS1182
In Commercial Distribution

  • D832THS11822 ()
  • D832THS11821 ()
  • D832THS11820 ()
THS1182

  • Medical equipment drape, single-use
Touch Screen Barrier Film, Smartphone, 8" X 8"
PLASDENT CORPORATION
THS0808
In Commercial Distribution

  • D832THS08082 ()
  • D832THS08081 ()
  • D832THS08080 ()
THS0808

  • Medical equipment drape, single-use
Sterilization Tubing, 6" X 100'
PLASDENT CORPORATION
ST6006
In Commercial Distribution

  • D832ST60062 ()
  • D832ST60061 ()
  • D832ST60060 ()
ST6006

  • Medical equipment drape, single-use
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