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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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Axcent Acrylics - D79331003010

Premium Dk Fiber 1lb
GARRECO, LLC
3100301
In Commercial Distribution

  • D79331003011 ()
  • D79331003010 ()
3100301

  • Dental appliance fabrication material, resin

Axcent Acrylics - D79331002050

Premium Lt Fiber 5lb
GARRECO, LLC
3100205
In Commercial Distribution

  • D79331002051 ()
  • D79331002050 ()
3100205

  • Dental appliance fabrication material, resin

Axcent Acrylics - D79331002010

PREMIUM DNT BASE LT FIBER HC 1 LB
GARRECO, LLC
3100201
In Commercial Distribution

  • D79331002011 ()
  • D79331002010 ()
3100201

  • Dental appliance fabrication material, resin

PureLife Dental - D79011901051

5 1/4" x 10" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink
PURELIFE, LLC
1190105
In Commercial Distribution

  • D79011901053 ()
  • D79011901051 ()
  • D79011901050 ()

  • 5-1/4" X 10"
1190105

  • Sterilization packaging, single-use

PureLife Dental - D79011901031

3 1/2" x 5 1/4" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink
PURELIFE, LLC
1190103
In Commercial Distribution

  • D79011901033 ()
  • D79011901031 ()
  • D79011901030 ()

  • 3-1/2" X 5-1/4"
1190103

  • Sterilization packaging, single-use

PureLife N95 - D79011548011

PureLife N95 Respirator, Disposable N95, Niosh approved N95 respirator, Headband-style, surgical respirator, Electrostatically-charged filter media provides low breathing resistance, Latex-free, staple-free head straps for comfort and safety, Soft foam nose cushion
PURELIFE, LLC
1154801
In Commercial Distribution

  • D79011548013 ()
  • D79011548011 ()
  • D79011548010 ()
1154801

  • Surgical/medical respirator, non-antimicrobial, single-use

PureLife Dental - D79011501011

Blue Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex-free ear loops, Metal nose piece
PURELIFE, LLC
1150101
In Commercial Distribution

  • D79011501013 ()
  • D79011501011 ()
  • D79011501010 ()
1150101

  • Surgical/medical face mask, single-use

PureLife Dental - D79011430021

Clear/Blue Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comfort, Specially-designed tip ensures optimal suction
PURELIFE, LLC
1143002
Not in Commercial Distribution

  • D79011430023 ()
  • D79011430021 ()
  • D79011430020 ()
1143002

  • Dental suction system cannula, single-use

PureLife Dental - D79011103011

2" x 2" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
PURELIFE, LLC
1110301
In Commercial Distribution

  • D79011103010 ()
  • D79011103011 ()
  • D79011103013 ()
1110301

  • Non-woven gauze pad, non-sterile

PureOrtho - D79010685041

PureOrtho Nitrile Powder-Free, Large, Nitrile powder-free gloves, Tiffany blue in color, Packaging contains recycled material
PURELIFE, LLC
1068504
In Commercial Distribution

  • D79010685043 ()
  • D79010685041 ()
  • D79010685040 ()
1068504

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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