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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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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
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
The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
IB-STIM
In Commercial Distribution

  • B960NSS2031 ()
  • B960NSS203 ()
  • B960NSS2032 ()
  • B327NSS203 ()
  • B960NSS2033 ()
01-1020

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
NeuroStim
In Commercial Distribution

  • B960NSS201 ()
  • B960NSS2011 ()
  • B960NSS2012 ()
  • B327NSS201 ()
  • B960NSS2013 ()
01-1021

  • Acupuncture electrical stimulation system
The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination. NSS-2 BRIDGE stimulator is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS-2 BRIDGE stimulator is placed behind the patient’s ear and connected to stimulation needles on the auricle. NSS-2 BRIDGE stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
Bridge
In Commercial Distribution

  • B960NSS2001 ()
  • B960NSS200 ()
  • B960NSS2002 ()
  • B327NSS200 ()
  • B960NSS2003 ()
01-1017-NSS-2/BRIDGE

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Patch for use with the SPEAX Digital Communication System for Home Use
ATAIA INC.
FGN-010
In Commercial Distribution

  • B792FGN010 ()
  • B792FGN014 ()
  • B792FGN015 ()
  • B792FGN016 ()
FGN010

  • Voice amplification system
VPS Putty Fast Set 300ml. each Base & Catalyst - MARK3 EU
CARGUS INTERNATIONAL, INC
1161
In Commercial Distribution

  • D796116110 ()
  • D79611612 ()
  • D79611613 ()
  • D79611614 ()


  • Silicone dental impression material
VPS Putty Regular Set 300ml. each Base & Catalyst - MARK3 EU
CARGUS INTERNATIONAL, INC
1160
In Commercial Distribution

  • D79611601 ()
  • D79611602 ()
  • D79611603 ()
  • D79611604 ()


  • Silicone dental impression material
eXact VPS 380 Impression Material Monophase Regular Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
1153
In Commercial Distribution

  • D7961153 ()
  • D79611531 ()
  • D79611532 ()
  • D79611533 ()
  • D79611534 ()
1153

  • Silicone dental impression material
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