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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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MoniTorr™ ICP and LimiTorr™ External CSF Drainage System Replacement Bag
Integra Lifesciences Corporation
INS2101
In Commercial Distribution

  • 10381780071051 ()
  • M269INS21011 ()

  • 500ml
INS2101

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
External fixation system for acute dorsal fracture dislocations of the PIP joint.
Hand Biomechanics Lab Inc
FCS-400
Not in Commercial Distribution

  • 00861994000229 ()


  • Orthopaedic bone pin, non-bioabsorbable
External Catheter Segment for Hickman 7F Pediatric Dual-Lumen CV Catheters Repair Kit
Bard Access Systems, Inc.
0601760
In Commercial Distribution

  • 10801741036481 ()
  • 00801741036484 ()

  • Catheter Gauge: 7 French
0601760

  • Central venous catheter repair kit
fixation pins without thread, smooth
WALDEMAR LINK GmbH & Co. KG
10-1534/29
Not in Commercial Distribution

  • 04026575229444 ()
10-1534/29

  • External orthopaedic fixation system, reusable
fixation pins with thread,Thread length 22 mm
WALDEMAR LINK GmbH & Co. KG
10-1534/19
Not in Commercial Distribution

  • 04026575229420 ()
10-1534/19

  • External orthopaedic fixation system, reusable
Soft Silicone Cover to use with LINK™ devices to protect from damage. This model is for use with parts 20mm in length and 10mm in width, 4 Pin configuration. These parts are replacement/supplemental in case of damage to original cover provided with LINK™ device.
METRIC MEDICAL DEVICES, INC.
CH2010
In Commercial Distribution

  • M963CH20100 ()
CH2010

  • External orthopaedic fixation system, single-use
Soft Silicone Cover to use with LINK™ devices to protect from damage. This model is for use with parts 20mm in length, 2 Pin configuration. These parts are replacement/supplemental in case of damage to original cover provided with LINK™ device.
METRIC MEDICAL DEVICES, INC.
C-20
In Commercial Distribution

  • M963C200 ()
C-20

  • External orthopaedic fixation system, single-use
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
fixation pins without thread, smooth
WALDEMAR LINK GmbH & Co. KG
10-1534/25
Not in Commercial Distribution

  • 04026575229437 ()
10-1534/25

  • External orthopaedic fixation system, reusable
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