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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Union Broach® Reamers #40 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12068
Not in Commercial Distribution

  • H834012120681 ()
  • 10381780481782 ()
  • 00381780481785 ()
012-12068

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #35 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12067
Not in Commercial Distribution

  • H834012120671 ()
  • 10381780481775 ()
  • 00381780481778 ()
012-12067

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #30 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12066
Not in Commercial Distribution

  • H834012120661 ()
  • 10381780481768 ()
  • 00381780481761 ()
012-12066

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #25 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12065
Not in Commercial Distribution

  • H834012120651 ()
  • 10381780481751 ()
  • 00381780481754 ()
012-12065

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #20 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12064
Not in Commercial Distribution

  • H834012120641 ()
  • 10381780481744 ()
  • 00381780481747 ()
012-12064

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #15 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12063
Not in Commercial Distribution

  • H834012120631 ()
  • 10381780481737 ()
  • 00381780481730 ()
012-12063

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #10 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12062
Not in Commercial Distribution

  • H834012120621 ()
  • 10381780481720 ()
  • 00381780481723 ()
012-12062

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #8 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12061
Not in Commercial Distribution

  • H834012120611 ()
  • 10381780481713 ()
  • 00381780481716 ()
012-12061

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #80 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12016
Not in Commercial Distribution

  • H834012120161 ()
  • 10381780481706 ()
  • 00381780481709 ()
012-12016

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #70 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12015
Not in Commercial Distribution

  • H834012120151 ()
  • 10381780481690 ()
  • 00381780481693 ()
012-12015

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #60 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12014
Not in Commercial Distribution

  • H834012120141 ()
  • 10381780481683 ()
  • 00381780481686 ()
012-12014

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #55 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12013
Not in Commercial Distribution

  • H834012120131 ()
  • 10381780481676 ()
  • 00381780481679 ()
012-12013

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #50 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12012
Not in Commercial Distribution

  • H834012120121 ()
  • 10381780481669 ()
  • 00381780481662 ()
012-12012

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #45 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12011
Not in Commercial Distribution

  • H834012120111 ()
  • 10381780481652 ()
  • 00381780481655 ()
012-12011

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #40 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12009
Not in Commercial Distribution

  • H834012120091 ()
  • 10381780481645 ()
  • 00381780481648 ()
012-12009

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #35 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12008
Not in Commercial Distribution

  • H834012120081 ()
  • 10381780481638 ()
  • 00381780481631 ()
012-12008

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #30 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12007
Not in Commercial Distribution

  • H834012120071 ()
  • 10381780481621 ()
  • 00381780481624 ()
012-12007

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #25 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12006
Not in Commercial Distribution

  • H834012120061 ()
  • 10381780481614 ()
  • 00381780481617 ()
012-12006

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #20 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12005
Not in Commercial Distribution

  • H834012120051 ()
  • 10381780481607 ()
  • 00381780481600 ()
012-12005

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #15 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12004
Not in Commercial Distribution

  • H834012120041 ()
  • 10381780481591 ()
  • 00381780481594 ()
012-12004

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #10 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12003
Not in Commercial Distribution

  • H834012120031 ()
  • 10381780481584 ()
  • 00381780481587 ()
012-12003

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #8 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12002
Not in Commercial Distribution

  • H834012120021 ()
  • 10381780481577 ()
  • 00381780481570 ()
012-12002

  • Manual endodontic file/rasp, single-use
Minimally Invasive Bunion Drill Guide
ARTHREX, INC.
AR-8741G
In Commercial Distribution

  • 00888867362673 ()
AR-8741G

  • Surgical drill guide, reusable
Minimally Invasive Bunion Corr System
ARTHREX, INC.
AR-8741C
In Commercial Distribution

  • 00888867367548 ()
AR-8741C

  • Device sterilization/disinfection container, reusable
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", Set of 9, Sizes 3mm To 11mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-8
In Commercial Distribution

  • H8341481 ()
  • 10381780360360 ()
14-8

  • Common bile duct dilator
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", 9mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-10-9
In Commercial Distribution

  • H834141091 ()
  • 10381780360216 ()
14-10-9

  • Common bile duct dilator
Catheter Adapter - Sterile
CUSTOM ASSEMBLIES, INC.
CMS-142
In Commercial Distribution

  • 00815849023130 ()
  • 00815849023147 ()


  • General-purpose catheter connector, sterile
CRW® Trunion Reticle Set
INTEGRA LIFESCIENCES CORPORATION
CRWTBSS
In Commercial Distribution

  • M248CRWTBSS1 ()
  • 10381780251996 ()


  • Stereotactic radiosurgical invasive head frame
No Description
ARTHREX, INC.
4mm x 130mm Sonoma CRx™ WG Sterile
Not in Commercial Distribution

  • 00816988011019 ()
CRX-WG2-40130-S

  • Clavicle intramedullary nail-like rod
No Description
ARTHREX, INC.
4mm x 120mm Sonoma CRx™ WG Sterile
Not in Commercial Distribution

  • 00816988011002 ()
CRX-WG2-40120-S

  • Clavicle intramedullary nail-like rod
No Description
ARTHREX, INC.
4mm x 110mm Sonoma CRx™ WG Sterile
Not in Commercial Distribution

  • 00816988010999 ()
CRX-WG2-40110-S

  • Clavicle intramedullary nail-like rod
No Description
ARTHREX, INC.
4mm x 100mm Sonoma CRx™ WG Sterile
Not in Commercial Distribution

  • 00816988010982 ()
CRX-WG2-40100-S

  • Clavicle intramedullary nail-like rod
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® Miltex® Bakes Common Duct Dilator, 8-1/2", 8mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-10-8
In Commercial Distribution

  • H834141081 ()
  • 10381780360209 ()
14-10-8

  • Common bile duct dilator
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", 7mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-10-7
In Commercial Distribution

  • H834141071 ()
  • 10381780360193 ()
14-10-7

  • Common bile duct dilator
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", 6mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-10-6
In Commercial Distribution

  • H834141061 ()
  • 10381780360186 ()
14-10-6

  • Common bile duct dilator
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", 5mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-10-5
In Commercial Distribution

  • H834141051 ()
  • 10381780360179 ()
14-10-5

  • Common bile duct dilator
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", 4mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-10-4
In Commercial Distribution

  • H834141041 ()
  • 10381780360162 ()
14-10-4

  • Common bile duct dilator
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", 3mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-10-3
In Commercial Distribution

  • H834141031 ()
  • 10381780360155 ()
14-10-3

  • Common bile duct dilator
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", 11mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-10-11
In Commercial Distribution

  • H8341410111 ()
  • 10381780360148 ()
14-10-11

  • Common bile duct dilator
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", 10mm Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
14-10-10
In Commercial Distribution

  • H8341410101 ()
  • 10381780360131 ()
14-10-10

  • Common bile duct dilator
ARTHREX ECLIPSE TRIAL TRUNION
ARTHREX, INC.
AR-9401-18
In Commercial Distribution

  • 00888867060340 ()
AR-9401-18

  • Humeral head prosthesis trial, reusable
ECLIPSE TRUNION IMPACTOR
ARTHREX, INC.
AR-9401-05
In Commercial Distribution

  • 00888867060265 ()
AR-9401-05

  • Orthopaedic inorganic implant inserter/extractor, reusable
UNIVERS II TRUNION EXTRACTOR
ARTHREX, INC.
AR-9202-38P
In Commercial Distribution

  • 00888867058569 ()
AR-9202-38P

  • Orthopaedic inorganic implant inserter/extractor, reusable
UNIVERS II TRIAL TRUNION
ARTHREX, INC.
AR-9202-27
In Commercial Distribution

  • 00888867058453 ()
AR-9202-27

  • Humeral head prosthesis trial, reusable
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