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 #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
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
TRUNION KIT FOR UNIVERS II
ARTHREX, INC.
AR-9100TK
In Commercial Distribution

  • 00888867134867 ()
  • M150AR9100TK2 ()
AR-9100TK

  • Uncoated shoulder humeral stem prosthesis
UNIVERS REVERS FRACTURE ADAPTER TRUNION
ARTHREX, INC.
AR-9501FTK
In Commercial Distribution

  • 00888867306004 ()
AR-9501FTK

  • Shoulder humeral body prosthesis
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
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
UNIVERS TRUNION KIT 6
ARTHREX, INC.
AR-9100-25
In Commercial Distribution

  • 00888867057265 ()
  • M150AR9100252 ()
AR-9100-25

  • Uncoated shoulder humeral stem prosthesis
UNIVERS TRUNION KIT 5
ARTHREX, INC.
AR-9100-24
In Commercial Distribution

  • 00888867057258 ()
  • M150AR9100242 ()
AR-9100-24

  • Uncoated shoulder humeral stem prosthesis
UNIVERS TRUNION KIT 4
ARTHREX, INC.
AR-9100-23
In Commercial Distribution

  • 00888867057241 ()
  • M150AR9100232 ()
AR-9100-23

  • Uncoated shoulder humeral stem prosthesis
UNIVERS TRUNION KIT 3
ARTHREX, INC.
AR-9100-22
In Commercial Distribution

  • 00888867057234 ()
  • M150AR9100222 ()
AR-9100-22

  • Uncoated shoulder humeral stem prosthesis
UNIVERS TRUNION KIT 2
ARTHREX, INC.
AR-9100-21
In Commercial Distribution

  • 00888867057227 ()
  • M150AR9100212 ()
AR-9100-21

  • Uncoated shoulder humeral stem prosthesis
UNIVERS TRUNION KIT 1
ARTHREX, INC.
AR-9100-20
In Commercial Distribution

  • 00888867057210 ()
  • M150AR9100202 ()
AR-9100-20

  • Uncoated shoulder humeral stem prosthesis
Specialty Reunion RSA Baseplate Centering Guide Assy
Howmedica Osteonics Corp.
I-U0262CG0R
In Commercial Distribution

  • 07613327359558 ()

  • Side: RIGHT
I-U0262CG0R

  • Orthopaedic implant aiming arm
Specialty Reunion RSA Baseplate Centering Guide Assy
Howmedica Osteonics Corp.
I-U0262CG0L
In Commercial Distribution

  • 07613327359541 ()

  • Side: LEFT
I-U0262CG0L

  • Orthopaedic implant aiming arm
X3 PEGGED GLENOID
Stryker GmbH
5542-P-0044-A
Not in Commercial Distribution

  • 07613327355475 ()
5542-P-0044-A

  • Total shoulder prosthesis
X3 PEGGED GLENOID
Stryker GmbH
5542-P-0052-E
In Commercial Distribution

  • 07613327355468 ()
5542-P-0052-E

  • Total shoulder prosthesis
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