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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Forked Removal Tool
Stryker GmbH
5901-1186
In Commercial Distribution

  • 07613327099584 ()
5901-1186

  • Orthopaedic inorganic implant inserter/extractor, reusable
Humeral Calcar Planar - Small
Stryker GmbH
5901-1180
In Commercial Distribution

  • 07613327099553 ()
5901-1180

  • Bone-resection orthopaedic reamer, single-use
Humeral Broach
Stryker GmbH
5901-1016
In Commercial Distribution

  • 07613327099539 ()

  • Diameter: 16.0 Millimeter
5901-1016

  • Orthopaedic broach
Dual Radius Humeral Head
Howmedica Osteonics Corp.
R5352-4018
In Commercial Distribution

  • 07613327139778 ()

  • Thickness: 18.0 Millimeter
  • Diameter: 40.0 Millimeter
R5352-4018

  • Total shoulder prosthesis
Dual Radius Humeral Head
Howmedica Osteonics Corp.
R5352-4518
In Commercial Distribution

  • 07613327139723 ()

  • Diameter: 45.0 Millimeter
  • Thickness: 18.0 Millimeter
R5352-4518

  • Total shoulder prosthesis
Albert Vein Institute
Gri-Alleset, Inc.
682-257R1
In Commercial Distribution

  • 10840365902116 ()
  • 00840365902119 ()


  • General surgical procedure kit, non-medicated, single-use
Vein & Vascular Institute
Gri-Alleset, Inc.
682-416
In Commercial Distribution

  • 10840365902024 ()
  • 00840365902027 ()


  • General surgical procedure kit, non-medicated, single-use
Albert Vein Institute, Lon Location Only
Gri-Alleset, Inc.
682-1349R1
In Commercial Distribution

  • 10840365900211 ()
  • 00840365900214 ()


  • General surgical procedure kit, non-medicated, single-use
BUNION PACK
Cardinal Health 200, LLC
SBACGBNNS6
In Commercial Distribution

  • 50195594638175 ()
  • 10195594638177 ()
SBACGBNNS6

  • Orthopaedic surgical procedure kit, medicated
NEUROLOGY INSTITUTE PACK
Cardinal Health 200, LLC
SNE29NEAK9
In Commercial Distribution

  • 50195594636430 ()
  • 10195594636432 ()
SNE29NEAK9

  • Neurosurgical procedure kit, non-medicated, single-use
BUNION PACK
Cardinal Health 200, LLC
SOPCGBNTF5
In Commercial Distribution

  • 50195594623980 ()
  • 10195594623982 ()
SOPCGBNTF5

  • Orthopaedic surgical procedure kit, medicated
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWB2
In Commercial Distribution

  • 50195594785275 ()
  • 10195594785277 ()
SOPMIBPWB2

  • General surgical procedure kit, medicated
CUSTOM SURGICAL KIT VEIN PACK
STRADIS MEDICAL, LLC
682-1400
Not in Commercial Distribution

  • M75268214001 ()


  • General surgical procedure kit, non-medicated, single-use
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM34
In Commercial Distribution

  • 50195594789679 ()
  • 10195594789671 ()
SCV31HVM34

  • Cardiothoracic surgical procedure kit, medicated, single-use
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWBB
In Commercial Distribution

  • 50195594788016 ()
  • 10195594788018 ()
SOPMIBPWBB

  • General surgical procedure kit, medicated
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWB1
In Commercial Distribution

  • 50195594763655 ()
  • 10195594763657 ()
SOPMIBPWB1

  • General surgical procedure kit, medicated
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM31
In Commercial Distribution

  • 50195594648020 ()
  • 10195594648022 ()
SCV31HVM31

  • Cardiothoracic surgical procedure kit, medicated, single-use
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVMYK
In Commercial Distribution

  • 50195594604071 ()
  • 10195594604073 ()
SCV31HVMYK

  • Cardiothoracic surgical procedure kit, medicated, single-use
Symmetry® Dilator, Bakes Common Duct, 7 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0507
In Commercial Distribution

  • 00887482075135 ()

  • Length: 8.5 Inch
  • Width: 7 Millimeter
51-0507

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 6 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0506
In Commercial Distribution

  • 00887482075128 ()

  • Length: 8.5 Inch
  • Width: 6 Millimeter
51-0506

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 5 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0505
In Commercial Distribution

  • 00887482075111 ()

  • Length: 8.5 Inch
  • Width: 5 Millimeter
51-0505

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 4 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0504
In Commercial Distribution

  • 00887482075104 ()

  • Length: 8.5 Inch
  • Width: 4 Millimeter
51-0504

  • Common bile duct dilator
DYNABUNION IM RADIOLUCENT REDUCER
CROSSROADS EXTREMITY SYSTEMS
DYNABUNION IM RADIOLUCENT REDUCER
In Commercial Distribution

  • 00810112598711 ()
280260PKG

  • Bone-resection orthopaedic reamer, reusable
DYNABUNION RE-CUT GUIDE
CROSSROADS EXTREMITY SYSTEMS
DYNABUNION RE-CUT GUIDE
In Commercial Distribution

  • 00810112598292 ()
280275PKG

  • Surgical drill guide, reusable
DYNABUNION SHORT PLATE TEMPLATE- LT
CROSSROADS EXTREMITY SYSTEMS
DYNABUNION SHORT PLATE TEMPLATE- LT
In Commercial Distribution

  • 00810112598131 ()
TEM270312PKG

  • Surgical implant template, reusable
DYNABUNION STANDARD PLATE TEMPLATE- LT
CROSSROADS EXTREMITY SYSTEMS
DYNABUNION STANDARD PLATE TEMPLATE- LT
In Commercial Distribution

  • 00810112598100 ()
TEM270308PKG

  • Surgical implant template, reusable
MiniBunion Saw Guide
CROSSROADS EXTREMITY SYSTEMS
MiniBunion Saw Guide
In Commercial Distribution

  • 00810112597875 ()
280041PKG

  • Surgical drill guide, reusable
MIS Bunion Plate Inserter
CROSSROADS EXTREMITY SYSTEMS
MIS Bunion Plate Inserter
In Commercial Distribution

  • 00810112597868 ()
280015PKG

  • Orthopaedic inorganic implant inserter/extractor, reusable
MiniBunion Instruments Tray
CROSSROADS EXTREMITY SYSTEMS
MiniBunion Instruments Tray
In Commercial Distribution

  • 00810112597851 ()
280020PKG

  • Instrument tray, reusable
MiniBunion Non-Locking Drill Guide
CROSSROADS EXTREMITY SYSTEMS
MiniBunion Non-Locking Drill Guide
In Commercial Distribution

  • 00810112597844 ()
280012PKG

  • Surgical drill guide, reusable
Ergonomic Toe Separators (Medium)
VIVE HEALTH LLC
INS1059BLUM
In Commercial Distribution

  • 10810113575480 ()
  • 00810113575483 ()


  • Toe separator
U Shaped Felt Callus Pads
VIVE HEALTH LLC
INS1058BGE
In Commercial Distribution

  • 10810113574278 ()
  • 00810113574271 ()


  • Foot friction/impact protector
Shock Absorbing Heel Cup (Large)
VIVE HEALTH LLC
INS1057DBLUL
In Commercial Distribution

  • 10810113573103 ()
  • 00810113573106 ()


  • Foot friction/impact protector
Shock Absorbing Heel Cup (Medium)
VIVE HEALTH LLC
INS1057DBLUM
In Commercial Distribution

  • 10810113573097 ()
  • 00810113573090 ()


  • Foot friction/impact protector
Shock Absorbing Heel Cup (Small)
VIVE HEALTH LLC
INS1057DBLUS
In Commercial Distribution

  • 10810113573080 ()
  • 00810113573083 ()


  • Foot friction/impact protector
Shock Absorbing Heel Cup (XS)
VIVE HEALTH LLC
INS1057DBLUXS
In Commercial Distribution

  • 10810113573073 ()
  • 00810113573076 ()


  • Foot friction/impact protector
Shock Absorbing Heel Cup (XXS)
VIVE HEALTH LLC
INS1057DBLUXXS
In Commercial Distribution

  • 10810113573066 ()
  • 00810113573069 ()


  • Foot friction/impact protector
Fabric Gel Heel Protectors (Beige)
VIVE HEALTH LLC
INS1055BGE
In Commercial Distribution

  • 00810113570211 ()


  • Foot friction/impact protector
Fabric Gel Heel Protectors (Black)
VIVE HEALTH LLC
INS1055BLK
In Commercial Distribution

  • 10810113570201 ()
  • 00810113570204 ()


  • Foot friction/impact protector
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
17.5° IM - 15° FP Right - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591514 ()
TG17-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
15° IM - 15° FP Right - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591507 ()
TG01-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
12.5° IM - 15° FP Right - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591491 ()
TG12-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
10° IM - 15° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591484 ()
TG01-015R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
7.5° IM - 15° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591477 ()
TG07-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
5° IM - 15° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591460 ()
TG00-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
DYNABUNION CUT GUIDE
CROSSROADS EXTREMITY SYSTEMS
DYNABUNION CUT GUIDE
In Commercial Distribution

  • 00810112598308 ()
280274PKG

  • Surgical drill guide, reusable
Compressor Block, Size 3
CROSSROADS EXTREMITY SYSTEMS
Compressor Block, Size 3
In Commercial Distribution

  • 00810112598285 ()
280289PKG

  • Orthopaedic instrument surgical connector
DynaBunion RACBlock, Size 2
CROSSROADS EXTREMITY SYSTEMS
DynaBunion RACBlock, Size 2
In Commercial Distribution

  • 00810112598247 ()
280285PKG

  • Orthopaedic instrument surgical connector
DynaBunion RACBlock, Size 1
CROSSROADS EXTREMITY SYSTEMS
DynaBunion RACBlock, Size 1
In Commercial Distribution

  • 00810112598230 ()
280284PKG

  • Orthopaedic instrument surgical connector
DynaBunion RAC Block, Size 0
CROSSROADS EXTREMITY SYSTEMS
DynaBunion RAC Block, Size 0
In Commercial Distribution

  • 00810112598193 ()
280283PKG

  • Orthopaedic instrument surgical connector
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