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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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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
Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.
BIO-MED DIAGNOSTICS, INC.
1080
In Commercial Distribution

  • B08810804 ()
  • B08810800 ()
  • B08810802 ()
  • B08810803 ()
10-8000

  • Neisseria gonorrhoeae culture isolate identification IVD, kit
The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-612C
In Commercial Distribution

  • M729800612C2 ()
  • M729800612C0 ()
  • M729800612C1 ()
  • M729800612C3 ()

  • Catheter Gauge: 6 to 12 French


  • Femoral artery closure plug/patch, collagen
Caretouch U-100 insulin syringe 31g 5/16" 8mm 0.5cc
Carelife (usa) Inc.
1
In Commercial Distribution

  • M992CTIS3150 ()
  • M992CTIS3151 ()
  • M992CTIS3153 ()
  • M992CTIS3155 ()
CTIS315

  • Insulin syringe/needle, basic
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