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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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
LINK™ External Fixator, 4 Pin, Square Configuration intended for assembly and use with appropriately sized Bone Pins designed to stabilize fractured bones, osteotomies or arthrodesis to promote treatment and healing. This is a single-use device that is provided sterile. A Silicone cover is provided within the package to assist with the protection of the LINK™ structure. The LINK™ External Fixator is indicated for use in the treatment of bone conditions including osteotomy, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. The LINK™ External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non-union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment.
METRIC MEDICAL DEVICES, INC.
4H201020
In Commercial Distribution

  • M9634H201020 ()

  • 4 Pin, H configuration, Pin Hole to Pin Hole 20mm in Length, 10mm in width
4H201020

  • External orthopaedic fixation system, single-use
LINK™ External Fixator, 2 Pin, Straight Configuration intended for assembly and use with appropriately sized Bone Pins designed to stabilize fractured bones, osteotomies, or arthrodesis to promote treatment and healing. This is a single-use device that is provided sterile. A silicone cover is provided within the package to assist with the protection of the LINK™ structure. The LINK™ External Fixator is indicated for use in the treatment of bone conditions including osteotomy, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. The LINK™ External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non-union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment.
METRIC MEDICAL DEVICES, INC.
2-200020
In Commercial Distribution

  • M96322000200 ()

  • 2 Pin, Linear, Pin Hole to Pin Hole 20mm in Length
2-200020

  • External orthopaedic fixation system, single-use
2.0 mm Diameter, Threaded Bone Pins as part of the LINK™ External Fixator, provided in a segregate package to allow for control of the amount of pins used per procedure. The LINK™ External Fixator is indicated for use in the treatment of bone conditions including osteotomy, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. The LINK™ External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non-union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment.
METRIC MEDICAL DEVICES, INC.
20TT
In Commercial Distribution

  • M96320TT0 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 6 Inch
20TT

  • External orthopaedic fixation system, single-use
2.0 mm Diameter, Threaded and Grooved Bone Pins as part of the LINK™ External Fixator, provided in a segregate package to allow for control of the amount of pins used per procedure. The LINK™ External Fixator is indicated for use in the treatment of bone conditions including osteotomy, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. The LINK™ External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non-union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment.
METRIC MEDICAL DEVICES, INC.
20TG
In Commercial Distribution

  • M96320TG0 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 6 Inch
  • Threaded, Grooved
20TG

  • External orthopaedic fixation system, single-use
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