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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 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
TYVEK ROLL 12"X200'
GS Medical Packaging Inc
551442PC
In Commercial Distribution

  • D830551442PC0 ()
  • D830551442PC9 ()
  • D830551442PC8 ()
  • D830551442PC7 ()


  • Sterilization packaging, single-use
TYVEK ROLL 6"X200'
GS Medical Packaging Inc
551436PC
In Commercial Distribution

  • D830551436PC0 ()
  • D830551436PC9 ()
  • D830551436PC8 ()
  • D830551436PC6 ()


  • Sterilization packaging, single-use
Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation
Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation
Autoclave Pouches 7 1/2" x 13", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH712135 ()
  • D832POH71213 ()
  • D832POH712131 ()
  • D832POH712132 ()
POH712-13

  • Sterilization packaging, single-use
Autoclave Pouches 5 1/4" x 10", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH514105 ()
  • D832POH51410 ()
  • D832POH514101 ()
  • D832POH514102 ()
POH514-10

  • Sterilization packaging, single-use
Autoclave Pouches 4 1/4" x 12", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH414125 ()
  • D832POH41412 ()
  • D832POH414121 ()
  • D832POH414122 ()
POH414-12

  • Sterilization packaging, single-use
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