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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Flex-R® Files - Flexible Roane Tip #130 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14082
Not in Commercial Distribution

  • H834012140821 ()
  • 10381780482314 ()
  • 00381780482317 ()
012-14082

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #120 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14081
Not in Commercial Distribution

  • H834012140811 ()
  • 10381780482307 ()
  • 00381780482300 ()
012-14081

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #110 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14079
Not in Commercial Distribution

  • H834012140791 ()
  • 10381780482291 ()
  • 00381780482294 ()
012-14079

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #100 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14078
Not in Commercial Distribution

  • H834012140781 ()
  • 10381780482284 ()
  • 00381780482287 ()
012-14078

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #90 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14077
Not in Commercial Distribution

  • H834012140771 ()
  • 10381780482277 ()
  • 00381780482270 ()
012-14077

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #80 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14075
Not in Commercial Distribution

  • H834012140751 ()
  • 10381780482260 ()
  • 00381780482263 ()
012-14075

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #70 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14074
Not in Commercial Distribution

  • H834012140741 ()
  • 10381780482253 ()
  • 00381780482256 ()
012-14074

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #60 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14073
Not in Commercial Distribution

  • H834012140731 ()
  • 10381780482246 ()
  • 00381780482249 ()
012-14073

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #55 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14072
Not in Commercial Distribution

  • H834012140721 ()
  • 10381780482239 ()
  • 00381780482232 ()
012-14072

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #50 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14071
Not in Commercial Distribution

  • H834012140711 ()
  • 10381780482222 ()
  • 00381780482225 ()
012-14071

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #45 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14070
Not in Commercial Distribution

  • H834012140701 ()
  • 10381780482215 ()
  • 00381780482218 ()
012-14070

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #40 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14068
Not in Commercial Distribution

  • H834012140681 ()
  • 10381780482208 ()
  • 00381780482201 ()
012-14068

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #35 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14067
Not in Commercial Distribution

  • H834012140671 ()
  • 10381780482192 ()
  • 00381780482195 ()
012-14067

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #30 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14066
Not in Commercial Distribution

  • H834012140661 ()
  • 10381780482185 ()
  • 00381780482188 ()
012-14066

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #25 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14065
Not in Commercial Distribution

  • H834012140651 ()
  • 10381780482178 ()
  • 00381780482171 ()
012-14065

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #20 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14064
Not in Commercial Distribution

  • H834012140641 ()
  • 10381780482161 ()
  • 00381780482164 ()
012-14064

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #15 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14063
Not in Commercial Distribution

  • H834012140631 ()
  • 10381780482154 ()
  • 00381780482157 ()
012-14063

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #10 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14062
Not in Commercial Distribution

  • H834012140621 ()
  • 10381780482147 ()
  • 00381780482140 ()
012-14062

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #8 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14061
Not in Commercial Distribution

  • H834012140611 ()
  • 10381780482130 ()
  • 00381780482133 ()
012-14061

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #80 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14016
Not in Commercial Distribution

  • H834012140161 ()
  • 10381780482123 ()
  • 00381780482126 ()
012-14016

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #70 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14015
Not in Commercial Distribution

  • H834012140151 ()
  • 10381780482116 ()
  • 00381780482119 ()
012-14015

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #60 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14014
Not in Commercial Distribution

  • H834012140141 ()
  • 10381780482109 ()
  • 00381780482102 ()
012-14014

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #55 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14013
Not in Commercial Distribution

  • H834012140131 ()
  • 10381780482093 ()
  • 00381780482096 ()
012-14013

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #50 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14012
Not in Commercial Distribution

  • H834012140121 ()
  • 10381780482086 ()
  • 00381780482089 ()
012-14012

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #45 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14011
Not in Commercial Distribution

  • H834012140111 ()
  • 10381780482079 ()
  • 00381780482072 ()
012-14011

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #40 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14009
Not in Commercial Distribution

  • H834012140091 ()
  • 10381780482062 ()
  • 00381780482065 ()
012-14009

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #35 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14008
Not in Commercial Distribution

  • H834012140081 ()
  • 10381780482055 ()
  • 00381780482058 ()
012-14008

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #30 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14007
Not in Commercial Distribution

  • H834012140071 ()
  • 10381780482048 ()
  • 00381780482041 ()
012-14007

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #25 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14006
Not in Commercial Distribution

  • H834012140061 ()
  • 10381780482031 ()
  • 00381780482034 ()
012-14006

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #20 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14005
Not in Commercial Distribution

  • H834012140051 ()
  • 10381780482024 ()
  • 00381780482027 ()
012-14005

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #15 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14004
Not in Commercial Distribution

  • H834012140041 ()
  • 10381780482017 ()
  • 00381780482010 ()
012-14004

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #10 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14003
Not in Commercial Distribution

  • H834012140031 ()
  • 10381780482000 ()
  • 00381780482003 ()
012-14003

  • Manual endodontic file/rasp, single-use
Flex-R® Files - Flexible Roane Tip #8 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-14002
Not in Commercial Distribution

  • H834012140021 ()
  • 10381780481997 ()
  • 00381780481990 ()
012-14002

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #80 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12195
Not in Commercial Distribution

  • H834012121951 ()
  • 10381780481980 ()
  • 00381780481983 ()
012-12195

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #70 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12194
Not in Commercial Distribution

  • H834012121941 ()
  • 10381780481973 ()
  • 00381780481976 ()
012-12194

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #60 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12193
Not in Commercial Distribution

  • H834012121931 ()
  • 10381780481966 ()
  • 00381780481969 ()
012-12193

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #55 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12192
Not in Commercial Distribution

  • H834012121921 ()
  • 10381780481959 ()
  • 00381780481952 ()
012-12192

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #50 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12191
Not in Commercial Distribution

  • H834012121911 ()
  • 10381780481942 ()
  • 00381780481945 ()
012-12191

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #45 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12190
Not in Commercial Distribution

  • H834012121901 ()
  • 10381780481935 ()
  • 00381780481938 ()
012-12190

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #40 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12188
Not in Commercial Distribution

  • H834012121881 ()
  • 10381780481928 ()
  • 00381780481921 ()
012-12188

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #35 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12187
Not in Commercial Distribution

  • H834012121871 ()
  • 10381780481911 ()
  • 00381780481914 ()
012-12187

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #30 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12186
Not in Commercial Distribution

  • H834012121861 ()
  • 10381780481904 ()
  • 00381780481907 ()
012-12186

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #25 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12185
Not in Commercial Distribution

  • H834012121851 ()
  • 10381780481898 ()
  • 00381780481891 ()
012-12185

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #20 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12184
Not in Commercial Distribution

  • H834012121841 ()
  • 10381780481881 ()
  • 00381780481884 ()
012-12184

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #15 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12183
Not in Commercial Distribution

  • H834012121831 ()
  • 10381780481874 ()
  • 00381780481877 ()
012-12183

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #10 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12182
Not in Commercial Distribution

  • H834012121821 ()
  • 10381780481867 ()
  • 00381780481860 ()
012-12182

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #8 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12181
Not in Commercial Distribution

  • H834012121811 ()
  • 10381780481850 ()
  • 00381780481853 ()
012-12181

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #80 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12075
Not in Commercial Distribution

  • H834012120751 ()
  • 10381780481843 ()
  • 00381780481846 ()
012-12075

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #70 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12074
Not in Commercial Distribution

  • H834012120741 ()
  • 10381780481836 ()
  • 00381780481839 ()
012-12074

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #60 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12073
Not in Commercial Distribution

  • H834012120731 ()
  • 10381780481829 ()
  • 00381780481822 ()
012-12073

  • Manual endodontic file/rasp, single-use
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