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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ECLIPSE TRUNION 41MM, SLOTTED, TPS CaP
ARTHREX, INC.
AR-9301-41CPC
In Commercial Distribution

  • 00888867276130 ()
AR-9301-41CPC

  • Coated shoulder humeral stem prosthesis
ECLIPSE TRUNION 39MM, SLOTTED, TPS CaP
ARTHREX, INC.
AR-9301-39CPC
In Commercial Distribution

  • 00888867276123 ()
AR-9301-39CPC

  • Coated shoulder humeral stem prosthesis
ECLIPSE TRUNION 37MM, SLOTTED, TPS CaP
ARTHREX, INC.
AR-9301-37CPC
In Commercial Distribution

  • 00888867276116 ()
AR-9301-37CPC

  • Coated shoulder humeral stem prosthesis
Union Broach® Reamers, Assortment #45-80 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12196
Not in Commercial Distribution

  • H834012121961 ()
  • 10381780486077 ()
012-12196

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers, Assortment #15-40 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12189
Not in Commercial Distribution

  • H834012121891 ()
  • 10381780486060 ()
012-12189

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers, Assortment #45-80 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12076
Not in Commercial Distribution

  • H834012120761 ()
  • 10381780486053 ()
012-12076

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers, Assortment #15-40 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12069
Not in Commercial Distribution

  • H834012120691 ()
  • 10381780486046 ()
012-12069

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers, Assortment #45-80 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12017
Not in Commercial Distribution

  • H834012120171 ()
  • 10381780486039 ()
012-12017

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers, Assortment #15-40 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12010
Not in Commercial Distribution

  • H834012120101 ()
  • 10381780486022 ()
012-12010

  • Manual endodontic file/rasp, single-use
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", 11mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140109
In Commercial Distribution

  • M2741401091 ()
  • 10381780379218 ()
140-109

  • Common bile duct dilator
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", 10mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140108
In Commercial Distribution

  • M2741401081 ()
  • 10381780379201 ()
140-108

  • Common bile duct dilator
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", 9mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140107
In Commercial Distribution

  • M2741401071 ()
  • 10381780379195 ()
140-107

  • Common bile duct dilator
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", 8mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140106
In Commercial Distribution

  • M2741401061 ()
  • 10381780379188 ()
140-106

  • Common bile duct dilator
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", 7mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140105
In Commercial Distribution

  • M2741401051 ()
  • 10381780379171 ()
140-105

  • Common bile duct dilator
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", 6mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140104
In Commercial Distribution

  • M2741401041 ()
  • 10381780379164 ()
140-104

  • Common bile duct dilator
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", 5mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140103
In Commercial Distribution

  • M2741401031 ()
  • 10381780379157 ()
140-103

  • Common bile duct dilator
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", 4mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140102
In Commercial Distribution

  • M2741401021 ()
  • 10381780379140 ()
140-102

  • Common bile duct dilator
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", 3mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140101
In Commercial Distribution

  • M2741401011 ()
  • 10381780379133 ()
140-101

  • Common bile duct dilator
Integra® Jarit® Bakes Common Duct Dilator, 8-1/2", Set of 9, Sizes 3mm To 11mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
140100
In Commercial Distribution

  • M2741401001 ()
  • 10381780379126 ()
140-100

  • Common bile duct dilator
Minimally Invasive Bunion Corr System
ARTHREX, INC.
AR-8741C
In Commercial Distribution

  • 00888867367548 ()
AR-8741C

  • Device sterilization/disinfection container, reusable
Minimally Invasive Bunion Drill Guide
ARTHREX, INC.
AR-8741G
In Commercial Distribution

  • 00888867362673 ()
AR-8741G

  • Surgical drill guide, reusable
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
Union Broach® Reamers #55 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12072
Not in Commercial Distribution

  • H834012120721 ()
  • 10381780481812 ()
  • 00381780481815 ()
012-12072

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #50 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12071
Not in Commercial Distribution

  • H834012120711 ()
  • 10381780481805 ()
  • 00381780481808 ()
012-12071

  • Manual endodontic file/rasp, single-use
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