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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
Universal Ground Clip (Pkg. of 2 pcs.)
PARKELL, INC.
D619GC
Not in Commercial Distribution

  • M595D619GC1 ()
  • M595D619GC0 ()
D619GC

  • Endodontic apex locator
Touch-Proof Wire Assembly for Model D-10 Foramatron® (Includes: Lip Clips, Quick Test Probe Reamer Holder & Touch-Proof Wire)
PARKELL, INC.
D611
Not in Commercial Distribution

  • M595D6110 ()
D611

  • Endodontic apex locator
Certified Refurbish The Foramatron® Electronic Apex Locator
PARKELL, INC.
D645CR
Not in Commercial Distribution

  • M595D645CR0 ()
D645CR

  • Endodontic apex locator
The Foramatron® Electronic Apex Locator
PARKELL, INC.
D645
Not in Commercial Distribution

  • M595D6450 ()
D645

  • Endodontic apex locator
Universal Reamer Holder for Foramatron® All Models
PARKELL, INC.
D619RH
Not in Commercial Distribution

  • M595D619RH0 ()
D619RH

  • Endodontic apex locator
Quick Probe for Foramatron® All Models
PARKELL, INC.
D613
Not in Commercial Distribution

  • M595D6130 ()
D613

  • Endodontic apex locator
E-Gasket Clear 120mm Round 300 Each
Keystone Industries
9604701R2
In Commercial Distribution

  • H6689604701R20 ()
  • H6689604701R21 ()
9604701R2

  • Dental appliance fabrication material, thermoplastic
E-Gasket Clear 125mm Round 300 Each
Keystone Industries
9604701R1
In Commercial Distribution

  • H6689604701R10 ()
  • H6689604701R11 ()
9604701R1

  • Dental appliance fabrication material, thermoplastic
E-Gasket Clear 300 Each
Keystone Industries
9604701
In Commercial Distribution

  • H66896047010 ()
  • H66896047011 ()
9604701

  • Dental appliance fabrication material, thermoplastic
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