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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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Buttress - M719GBP2200

Dual Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP2201 ()
  • M719GBP2200 ()

  • Length: 20 Millimeter
GBP2-20

  • Bone-screw internal spinal fixation system, non-sterile

Buttress - M719GBP1280

Single Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP1280 ()
  • M719GBP1281 ()

  • Length: 28 Millimeter
GBP1-28

  • Bone-screw internal spinal fixation system, non-sterile

Buttress - M719GBP1220

Single Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP1220 ()
  • M719GBP1221 ()

  • Length: 22 Millimeter
GBP1-22

  • Bone-screw internal spinal fixation system, non-sterile

Buttress - M719GBP2250

Dual Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP2251 ()
  • M719GBP2250 ()

  • Length: 25 Millimeter
GBP2-25

  • Bone-screw internal spinal fixation system, non-sterile

Buttress - M719GBP2220

Dual Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP2221 ()
  • M719GBP2220 ()

  • Length: 22 Millimeter
GBP-2-22

  • Bone-screw internal spinal fixation system, non-sterile

Buttress - M719GBP1250

Single Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP1250 ()
  • M719GBP1251 ()

  • Length: 25 Millimeter
GBP1-25

  • Bone-screw internal spinal fixation system, non-sterile

Buttress - M719GBP1200

Single Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP1200 ()
  • M719GBP1201 ()

  • Length: 20 Millimeter
GBP1-20

  • Bone-screw internal spinal fixation system, non-sterile

PURELIFE - D79011901061

STERILIZATION POUCHES - 7-1/2" X 12"
PURELIFE, LLC
1190106
Not in Commercial Distribution

  • D79011901063 ()
  • D79011901061 ()
  • D79011901060 ()

  • 7-1/2" X 12"
1190106

  • Sterilization packaging, single-use

PureLife Dental - D79011901041

3 1/2" x 9" 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
1190104
In Commercial Distribution

  • D79011901043 ()
  • D79011901041 ()
  • D79011901040 ()

  • 3-1/2" X 9"
1190104

  • Sterilization packaging, single-use

PureLife Dental - D79011901021

2 3/4" x 9" 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
1190102
In Commercial Distribution

  • D79011901023 ()
  • D79011901021 ()
  • D79011901020 ()

  • 2-3/4" X 9"
1190102

  • Sterilization packaging, single-use

PureLife Dental - D79011901011

2 1/4" x 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
1190101
In Commercial Distribution

  • D79011901013 ()
  • D79011901011 ()
  • D79011901010 ()

  • 2-1/4" X 4"
1190101

  • Sterilization packaging, single-use

PureLife Dental - D79011549021

PureLife Level 3 Masks Pink
PURELIFE, LLC
1154902
In Commercial Distribution

  • D79011549023 ()
  • D79011549021 ()
  • D79011549020 ()
1154902

  • Surgical/medical face mask, single-use

PureLife Dental - D79011549011

PureLife Level 3 Masks Blue
PURELIFE, LLC
1154901
In Commercial Distribution

  • D79011549013 ()
  • D79011549011 ()
  • D79011549010 ()
1154901

  • Surgical/medical face mask, single-use

PureLife Dental - D79011501021

Pink Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex-free ear loops, Metal nose piece
PURELIFE, LLC
1150102
In Commercial Distribution

  • D79011501023 ()
  • D79011501021 ()
  • D79011501020 ()
1150102

  • Surgical/medical face mask, single-use

PureLife Dental - D79011430011

White/White Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comfort, Specially-designed tip ensures optimal suction
PURELIFE, LLC
1143001
Not in Commercial Distribution

  • D79011430013 ()
  • D79011430011 ()
  • D79011430010 ()
1143001

  • Dental suction system cannula, single-use

PureLife Dental - D79011103021

4" x 4" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
PURELIFE, LLC
1110302
In Commercial Distribution

  • D79011103020 ()
  • D79011103021 ()
  • D79011103023 ()
1110302

  • Non-woven gauze pad, non-sterile

PureOrtho - D79010685051

PureOrtho Nitrile Powder-Free, X-Large, Nitrile powder-free gloves, Tiffany blue in color, Packaging contains recycled material
PURELIFE, LLC
1068505
In Commercial Distribution

  • D79010685053 ()
  • D79010685051 ()
  • D79010685050 ()
1068505

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

PureOrtho - D79010685031

PureOrtho Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Tiffany blue in color, Packaging contains recycled material
PURELIFE, LLC
1068503
In Commercial Distribution

  • D79010685033 ()
  • D79010685031 ()
  • D79010685030 ()
1068503

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

PureOrtho - D79010685011

PureOrtho Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Tiffany blue in color, Packaging contains recycled material
PURELIFE, LLC
1068501
In Commercial Distribution

  • D79010685013 ()
  • D79010685011 ()
  • D79010685010 ()
1068501

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

PureSense - D79010684041

PureSense Nitrile Powder-Free, Large, Nitrile powder-free gloves, Pink in color, Packaging contains recycled material
PURELIFE, LLC
1068404
In Commercial Distribution

  • D79010684043 ()
  • D79010684041 ()
  • D79010684040 ()
1068404

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

PureSense - D79010684021

PureSense Nitrile Powder-Free, Small, Nitrile powder-free gloves, Pink in color, Packaging contains recycled material
PURELIFE, LLC
1068402
In Commercial Distribution

  • D79010684023 ()
  • D79010684021 ()
  • D79010684020 ()
1068402

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

PureHorizon - D79010673041

Large, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recycled material
PURELIFE, LLC
1067304
Not in Commercial Distribution

  • D79010673043 ()
  • D79010673041 ()
  • D79010673040 ()
1067304

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

PureHorizon - D79010673021

Small, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recycled material
PURELIFE, LLC
1067302
Not in Commercial Distribution

  • D79010673023 ()
  • D79010673021 ()
  • D79010673020 ()
1067302

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

PureHorizon - D79010673011

X-Small, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recycled material
PURELIFE, LLC
1067301
Not in Commercial Distribution

  • D79010673013 ()
  • D79010673011 ()
  • D79010673010 ()
1067301

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

PureBerry - D79010671051

X-Large, Nitrile powder-free gloves, Textured fingertips, Berry-blue in color, Packaging contains recycled material
PURELIFE, LLC
1067105
In Commercial Distribution

  • D79010671053 ()
  • D79010671051 ()
  • D79010671050 ()
1067105

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

PureBerry - D79010671041

Large, Nitrile powder-free gloves, Textured fingertips, Berry-blue in color, Packaging contains recycled material
PURELIFE, LLC
1067104
In Commercial Distribution

  • D79010671043 ()
  • D79010671041 ()
  • D79010671040 ()
1067104

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

PureBerry - D79010671021

Small, Nitrile powder-free gloves, Textured fingertips, Berry-blue in color, Packaging contains recycled material
PURELIFE, LLC
1067102
In Commercial Distribution

  • D79010671023 ()
  • D79010671021 ()
  • D79010671020 ()
1067102

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

Azur - D79010617051

Azur Nitrile Powder-Free, X-Large, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061705
In Commercial Distribution

  • D79010617053 ()
  • D79010617051 ()
  • D79010617050 ()
1061705

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

Azur - D79010617031

Azur Nitrile Powder-Free, Medium, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061703
In Commercial Distribution

  • D79010617033 ()
  • D79010617031 ()
  • D79010617030 ()
1061703

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

Azur - D79010617021

Azur Nitrile Powder-Free, Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061702
In Commercial Distribution

  • D79010617023 ()
  • D79010617021 ()
  • D79010617020 ()
1061702

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

Azur - D79010617011

Azur Nitrile Powder-Free, X-Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061701
In Commercial Distribution

  • D79010617013 ()
  • D79010617011 ()
  • D79010617010 ()
1061701

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

SuperNova - D79010612041

SuperNova Nitrile Powder-Free, Large, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061204
In Commercial Distribution

  • D79010612043 ()
  • D79010612041 ()
  • D79010612040 ()
1061204

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

Nova - D79010601041

Nova Nitrile Powder-Free, Large, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060104
In Commercial Distribution

  • D79010601043 ()
  • D79010601041 ()
  • D79010601040 ()
1060104

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

Nova - D79010601011

Nova Nitrile Powder-Free, X-Small, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060101
In Commercial Distribution

  • D79010601013 ()
  • D79010601011 ()
  • D79010601010 ()
1060101

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

PureGuard - D79010240041

Large, Soft, nitrile powder-free, Textured fingertips, Packaging contains recycled material, Blue in color
PURELIFE, LLC
1024004
Not in Commercial Distribution

  • D79010240043 ()
  • D79010240041 ()
  • D79010240040 ()
1024004

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

Health-Tec Clear Fluoride Varnish - D773950100812

Health-Tec Clear Fluoride Varnish 0.5ml Melon 200 pack
Dental Health Products Inc
950-10081
In Commercial Distribution

  • D773950100813C ()
  • D773950100812 ()
  • D773950100810 ()

  • 0.5ml
950-10081

  • Dental coating, tooth-desensitizing

Health-Tec Clear Fluoride Varnish 0.5ml Mint 200 pack - D773950100802

Health-Tec Clear Fluoride Varnish 0.5ml Mint 200 pack
Dental Health Products Inc
950-10080
In Commercial Distribution

  • D773950100802 ()
  • D773950100800 ()
  • D773950100803 ()

  • 0.5ml
950-10080

  • Dental coating, tooth-desensitizing

Health-Tec Clear Fluoride Varnish - D773950100712

Health-Tec Clear Fluoride Varnish 0.5ml Melon 50 pack
Dental Health Products Inc
950-10071
In Commercial Distribution

  • D773950100713B ()
  • D773950100712 ()
  • D773950100710 ()

  • 0.5ml
950-10071

  • Dental coating, tooth-desensitizing

Health-Tec Clear Fluoride Varnish - D773950100702

Health-Tec Clear Fluoride Varnish 0.5ml Mint 50 pack
Dental Health Products Inc
950-10070
In Commercial Distribution

  • D773950100702 ()
  • D773950100700 ()
  • D773950100703 ()

  • 0.5ml
950-10070

  • Dental coating, tooth-desensitizing

Silk Black Braided 4-0 18" C6 - D773850S4018C61

No Description
Dental Health Products Inc
850-S4018C6
In Commercial Distribution

  • D773850S4018C61 ()
  • D773850S4018C62 ()
850-S4018C6

  • Silk suture
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