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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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No Description
BIOMET SPINE LLC
83116
In Commercial Distribution

  • 00880304979185 ()

  • ONE LEVEL 16MM PLATE
83116

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
83118
In Commercial Distribution

  • 00880304979178 ()

  • ONE LEVEL 18MM PLATE
83118

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
83120
In Commercial Distribution

  • 00880304979161 ()

  • ONE LEVEL 20MM PLATE
83120

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
83122
In Commercial Distribution

  • 00880304979154 ()

  • ONE LEVEL 22MM PLATE
83122

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
83124
In Commercial Distribution

  • 00880304979147 ()

  • ONE LEVEL 24MM PLATE
83124

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
83126
In Commercial Distribution

  • 00880304979130 ()

  • ONE LEVEL 26MM PLATE
83126

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
83128
In Commercial Distribution

  • 00880304979123 ()

  • ONE LEVEL 28MM PLATE
83128

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
83130
In Commercial Distribution

  • 00880304979116 ()

  • ONE LEVEL 30MM PLATE
83130

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
83136
In Commercial Distribution

  • 00880304979109 ()

  • ONE LEVEL 36MM PLATE
83136

  • Bone-screw internal spinal fixation system, non-sterile
Post Cement Paste/Paste Chemical Cure Natural Shade A3 Sample
ESSENTIAL DENTAL SYSTEMS, INC.
861-00
Not in Commercial Distribution

  • 00766054000242 ()

  • One 1 gram Syringe Base and One 1 gram Syringe Catalyst
861-00

  • Dental composite resin
Post Cement Paste/Paste Chemical Cure Gray Shade Sample
ESSENTIAL DENTAL SYSTEMS, INC.
851-00
Not in Commercial Distribution

  • 00766054000235 ()

  • One 1 gram Syringe Base and One 1 gram Syringe Catalyst
851-00

  • Dental composite resin
Post Cement Paste/Paste Chemical Cure Natural Shade A3 Sample
ESSENTIAL DENTAL SYSTEMS, INC.
811-00
Not in Commercial Distribution

  • 00766054000228 ()

  • One 2 gram Jar Base and One 2 gram Jar Catalyst
811-00

  • Dental composite resin
Post Cement Paste/Paste Chemical Cure Gray Shade Sample
ESSENTIAL DENTAL SYSTEMS, INC.
801-00
Not in Commercial Distribution

  • 00766054000211 ()

  • One 2 gram Jar Base and One 2 gram Jar Catalyst
801-00

  • Dental composite resin
Root Canal Cement Powder Jar/Gel Tube
ESSENTIAL DENTAL SYSTEMS, INC.
1608-00
In Commercial Distribution

  • 00766054000143 ()

  • One - 7.5 gram Gel Tube and One 8 gram powder Jar
1608-00

  • Hygroscopic dental cement
Root Canal Cement Powder Jar/Gel Tube with Bi-Directional Spirals Nickel Titanium
ESSENTIAL DENTAL SYSTEMS, INC.
1605-00
In Commercial Distribution

  • 00766054000136 ()

  • One - 7.5 gram Gel Tube and One 8 gram powder Jar
1605-00

  • Hygroscopic dental cement
Root Canal Cement Powder Jar/Gel Tube with Bi-Directional Spirals Stainless Steel
ESSENTIAL DENTAL SYSTEMS, INC.
1600-00
In Commercial Distribution

  • 00766054000129 ()

  • One - 7.5 gram Gel Tube and One 8 gram powder Jar
1600-00

  • Hygroscopic dental cement
Post Cement Paste/Paste Chemical Cure Natural Shade A3
ESSENTIAL DENTAL SYSTEMS, INC.
860-00
Not in Commercial Distribution

  • 00766054000075 ()

  • One 9 gram Syringe Base and One 9 gram Syringe Catalyst
860-00

  • Dental composite resin
Post Cement Paste/Paste Chemical Cure Gray Shade
ESSENTIAL DENTAL SYSTEMS, INC.
850-00
Not in Commercial Distribution

  • 00766054000068 ()

  • One 9 gram Syringe Base and One 9 gram Syringe Catalyst
850-00

  • Dental composite resin
Core Material Paste/Paste Chemical Cure Natural Shade A3 Fast Set
ESSENTIAL DENTAL SYSTEMS, INC.
815-00
In Commercial Distribution

  • 00766054000037 ()

  • One 15 gram Jar Base and One 15 gram Jar Catalyst
815-00

  • Custom-made dental composite resin kit
Core Material Paste/Paste Chemical Cure Natural Shade A3
ESSENTIAL DENTAL SYSTEMS, INC.
810-00
In Commercial Distribution

  • 00766054000020 ()

  • One 15 gram Jar Base and One 15 gram Jar Catalyst
810-00

  • Custom-made dental composite resin kit
Core Material Paste/Paste Chemical Cure Gray Shade Fast Set
ESSENTIAL DENTAL SYSTEMS, INC.
805-00
In Commercial Distribution

  • 00766054000013 ()

  • One 15 gram Jar Base and One 15 gram Jar Catalyst
805-00

  • Custom-made dental composite resin kit
Core Material Paste/Paste Chemical Cure Gray Shade
ESSENTIAL DENTAL SYSTEMS, INC.
800-00
In Commercial Distribution

  • 00766054000006 ()

  • One 15 gram Jar Base and One 15 gram Jar Catalyst
800-00

  • Custom-made dental composite resin kit
No Description
BIOMET SPINE LLC
4431-1034
In Commercial Distribution

  • 00887868166563 ()

  • Plate One Level Ti 34mm
4431-1034

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1032
In Commercial Distribution

  • 00887868166556 ()

  • Plate One Level Ti 32mm
4431-1032

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1030
In Commercial Distribution

  • 00887868166549 ()

  • Plate One Level Ti 30mm
4431-1030

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1028
In Commercial Distribution

  • 00887868166532 ()

  • Plate One Level Ti 28mm
4431-1028

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1026
In Commercial Distribution

  • 00887868166525 ()

  • Plate One Level Ti 26mm
4431-1026

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1024
In Commercial Distribution

  • 00887868166518 ()

  • Plate One Level Ti 24mm
4431-1024

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1022
In Commercial Distribution

  • 00887868166501 ()

  • Plate One Level Ti 22mm
4431-1022

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1020
In Commercial Distribution

  • 00887868166495 ()

  • Plate One Level Ti 20mm
4431-1020

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