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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 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
Diasol Sodium Bicarbonate Powder
DIASOL, INC.
BP10000- 25G / x25T
In Commercial Distribution

  • B467BP4525 ()
  • B467BP4525G3 ()
  • B467BP4524T2 ()
  • B4674525T1 ()
BP2/3 - BP9/10

  • Haemodialysis concentrate
Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45225-75100
In Commercial Distribution

  • B467ACP452257510016 ()
  • B467ACP4522575100 ()
  • B467ACP452257510020 ()
  • B467ACP452257510025 ()
ACP8/9/10

  • Haemodialysis concentrate
Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case
CELLERA LLC
30150
In Commercial Distribution

  • B492301500 ()
  • B492301501 ()
  • B492301502 ()
  • B492301503 ()
30150

  • Glucose IVD, kit, electrometry
Vitale Silicone Foam Dressings with Antibacterial Silver, 6"x6", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20066
In Commercial Distribution

  • B492200663 ()
  • B492200662 ()
  • B492200661 ()
  • B492200660 ()
20066

  • Exudate-absorbent dressing, non-gel, antimicrobial
Vitale Silicone Foam Dressings with Antibacterial Silver, 4"x4", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20044
In Commercial Distribution

  • B492200442 ()
  • B492200441 ()
  • B492200440 ()
  • B492200443 ()
20044

  • Exudate-absorbent dressing, non-gel, antimicrobial
The BE 125-1TD Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Can be used to easily add a monitoring device such as a temperature probe to the breathing circuit. Dimensions: 22mm O.D. x 22mm I.D. x 15mm I.D. Single Patient Use. Molded of High Density Polyethylene.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 125-1TD
In Commercial Distribution

  • M996BE1251TD6 ()
  • M996BE1251TD0 ()
  • M996BE1251TD3 ()
  • M996BE1251TD2 ()
BE 125-1TD

  • Straight/elbow breathing circuit connector, single-use
Ventilator Tubing Accessory - Swivel Tubing Clamp. Swivels 360 degrees; fits tubing and rails 1/2" to 1" inch diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 102
In Commercial Distribution

  • M996BE1026 ()
  • M996BE1020 ()
  • M996BE1025 ()
  • M996BE1023 ()
BE 102

  • Ventilator breathing circuit, single-use
Instrument Jaw Covers, White
AXIOM MEDICAL, INCORPORATED
300
In Commercial Distribution

  • M6653003 ()
  • M6653001 ()
  • M6653000 ()
  • M6653005 ()


  • Vascular booties
Retraction Tape, Mini, Blue, Veins
AXIOM MEDICAL, INCORPORATED
118
In Commercial Distribution

  • M6651185 ()
  • M6651183 ()
  • M6651181 ()
  • M6651180 ()


  • Surgical support tape, non-bioabsorbable
Retraction Tape, Mini, White, Nerves
AXIOM MEDICAL, INCORPORATED
117
In Commercial Distribution

  • M6651175 ()
  • M6651173 ()
  • M6651171 ()
  • M6651170 ()


  • Surgical support tape, non-bioabsorbable
Retraction Tape, Mini, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
116
In Commercial Distribution

  • M6651165 ()
  • M6651163 ()
  • M6651161 ()
  • M6651160 ()


  • Surgical support tape, non-bioabsorbable
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