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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-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
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
NEEDLE,23 X 1
American Health Service Sales Corporation
AHS2325RN
In Commercial Distribution

  • B031AHS2325RN2 ()
  • B031AHS2325RN1 ()
  • B031AHS2325RN0 ()
  • B031AHS2325RN3 ()


  • Hypodermic needle, single-use
12CC SYRINGE KIT
STRADIS MEDICAL LLC
HCT3548
In Commercial Distribution

  • M752HCT35485 ()
  • M752HCT35482 ()
  • M752HCT35481 ()
  • M752HCT35480 ()


  • General-purpose syringe, single-use
1CC SLIP TIP SYRINGES
STRADIS MEDICAL LLC
HCT1CC-ST
In Commercial Distribution

  • M752HCT1CCST5 ()
  • M752HCT1CCST0 ()
  • M752HCT1CCST1 ()


  • General-purpose syringe, single-use
10CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT10CC-LL
In Commercial Distribution

  • M752HCT10CCLL5 ()
  • M752HCT10CCLL1 ()
  • M752HCT10CCLL0 ()


  • General-purpose syringe, single-use
Upper Extremity Drape
STRADIS MEDICAL, LLC
IN-9300CLF
Not in Commercial Distribution

  • M752IN9300CLF5 ()
  • M752IN9300CLF1 ()
  • M752IN9300CLF3 ()


  • Patient surgical drape, single-use
Dressing Change kit w/Sorbaview
STRADIS MEDICAL, LLC
IM1259
Not in Commercial Distribution

  • M752IM12595 ()
  • M752IM12590 ()
  • M752IM12596 ()


  • Wound dressing kit, medicated
Dressing Change Tray
STRADIS MEDICAL LLC
IM1256
In Commercial Distribution

  • M752IM12665 ()
  • M752IM12560 ()
  • M752IM12565 ()


  • Wound dressing kit, non-medicated
Dressing Change Tray W/ Biopatch
STRADIS MEDICAL, LLC
HCT9948BP
Not in Commercial Distribution

  • M752HCT9948BP5 ()
  • M752HCT9948BP0 ()
  • M752HCT9948BP6 ()


  • Wound dressing kit, medicated
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