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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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NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS4030
In Commercial Distribution

  • B130NS40300 ()
  • B130NS40301 ()
  • B130NS40302 ()
  • B130NS40303 ()
NS4030

  • Nerve guide, animal-derived
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS3020
In Commercial Distribution

  • B130NS30201 ()
  • B130NS30200 ()
  • B130NS30202 ()
  • B130NS30203 ()
NS3020

  • Nerve guide, animal-derived
The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Medium size has lead body width of approximately 7mm.
Checkpoint Surgical, Inc.
9525
In Commercial Distribution

  • B13095251 ()
  • B13095250 ()
  • B13095252 ()
  • B13095253 ()

  • Width: 7 Millimeter
9525

  • Nerve-locating system
The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm.
Checkpoint Surgical, Inc.
9524
In Commercial Distribution

  • B13095241 ()
  • B13095240 ()
  • B13095242 ()
  • B13095243 ()

  • Width: 4 Millimeter
9524

  • Nerve-locating system
Probe Extension, 4 cm for use with Checkpoint Stimulators`
Checkpoint Surgical, Inc.
9506
In Commercial Distribution

  • B13095061 ()
  • B13095060 ()
  • B13095062 ()
  • B13095063 ()
9506

  • Nerve-locating system
Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators
Checkpoint Surgical, Inc.
9505
In Commercial Distribution

  • B13095051 ()
  • B13095050 ()
  • B13095052 ()
  • B13095053 ()
9505

  • Nerve-locating system
Probe Extension, 12 cm for use with Checkpoint Stimulators
Checkpoint Surgical, Inc.
9504
In Commercial Distribution

  • B13095041 ()
  • B13095040 ()
  • B13095042 ()
  • B13095043 ()
9504

  • Nerve-locating system
The CHECKPOINT EDGE™ Nerve Cutting Kit is a single-use, sterile kit intended to provide surgeon aid in transecting nerve tissue for the purpose of nerve graft preparation, nerve repair, or removal of exposed nerve. The kit includes three circumferential nerve constraining forceps, two blades, and a silicone visibility background.
Checkpoint Surgical, Inc.
9250
In Commercial Distribution

  • B13092501 ()
  • B13092500 ()
  • B13092502 ()
  • B13092503 ()
9250

  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use
Handheld Single-use Surgical Nerve Stimulator
Checkpoint Surgical, Inc.
9095
In Commercial Distribution

  • B13090951 ()
  • B13090950 ()
  • B13090952 ()
  • B13090953 ()
9095

  • Nerve-locating system
Handheld Single-use Surgical Bipolar Nerve Stimulator
Checkpoint Surgical, Inc.
9092
In Commercial Distribution

  • B13090921 ()
  • B13090920 ()
  • B13090922 ()
  • B13090923 ()
9092

  • Nerve-locating system
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