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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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LINK™ External Fixator - M9634H201020

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 - M96322000200

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

CABLE,EXTERNAL SIGNAL,IABP - 10607567104713

No Description
Datascope Corp.
0012-00-0323
In Commercial Distribution

  • 10607567104713 ()
0012-00-0323

  • Electrical-only medical device connection cable, reusable

External Talk Through Microphone - 00817020020372

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M025550
In Commercial Distribution

  • 00817020020372 ()


  • Freestanding microphone

External Fixator End cap - 07640136270460

Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
5020-1000
In Commercial Distribution

  • 07640136270460 ()


  • External orthopaedic fixation system, single-use

External Fixator Screw handle - 07640136270453

Reusable external orthopaedic fixation system instrument intended for implantation and/or tightening.
GEXFIX SA
5015-1000
In Commercial Distribution

  • 07640136270453 ()


  • General external orthopaedic fixation system implantation kit, reusable

External Fixator Drill brace - 07640136270446

Reusable external orthopaedic fixation system instrument intended for implantation and/or tightening.
GEXFIX SA
5010-1000
In Commercial Distribution

  • 07640136270446 ()


  • General external orthopaedic fixation system implantation kit, reusable

External Fixator Ring clamp - 07640136270279

Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1020-1010
In Commercial Distribution

  • 07640136270279 ()


  • External orthopaedic fixation system, single-use

Orthex External Fixation System - 00840194467001

SB Angled Pin Connector
ORTHOPEDIATRICS CORP.
01-2200-0422
In Commercial Distribution

  • 00840194467001 ()
01-2200-0422

  • Orthopaedic instrument surgical connector

Orthex External Fixation System - 00840194466998

Angled Pin Connector Short
ORTHOPEDIATRICS CORP.
01-2200-0421
In Commercial Distribution

  • 00840194466998 ()
01-2200-0421

  • Orthopaedic instrument surgical connector
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