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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.
KEY ELECTRONICS, INC.
Bridge
In Commercial Distribution

  • B327NSS200 ()
  • B327NSS2002 ()
  • B327NSS2001 ()
01-1017-NSS-2/Bridge

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Wired TENS+EMS+HEAT Replacement Gel Pads
BEAR DOWN CONSULTING
PETNEMPD5
In Commercial Distribution

  • B311PETNEMPD51 ()
  • B311PETNEMPD5 ()
  • B311PETNEMPD52 ()


  • Transcutaneous electrical stimulation electrode, single-use
Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets
BEAR DOWN CONSULTING
PETNEMPD2
In Commercial Distribution

  • B311PETNEMPD21 ()
  • B311PETNEMPD2 ()
  • B311PETNEMPD22 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
BEAR DOWN CONSULTING
PETNEMHT
In Commercial Distribution

  • B311PETNEMHT1 ()
  • B311PETNEMHT0 ()
  • B311PETNEMHT2 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
BEAR DOWN CONSULTING
PEPULSE-RT
In Commercial Distribution

  • B311PEPULSERT0 ()
  • B311PEPULSERT1 ()
  • B311PEPULSERT2 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS5
In Commercial Distribution

  • B311PEHTNPDS51 ()
  • B311PEHTNPDS50 ()
  • B311PEHTNPDS52 ()


  • Transcutaneous electrical stimulation electrode, single-use
Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS2
In Commercial Distribution

  • B311PEHTNPDS21 ()
  • B311PEHTNPDS20 ()
  • B311PEHTNPDS22 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
THERAVANT CORPORATION
30TC03000AA
In Commercial Distribution

  • B30530TC0300 ()
  • B30530TC0301 ()
  • B30530TC0302 ()
30TC030

  • Multi-modality skin surface treatment system generator
No Description
THERAVANT CORPORATION
20TC12900AA
In Commercial Distribution

  • B30520TC1290 ()
  • B30520TC1292 ()
  • B30520TC1291 ()
20TC129

  • Multi-modality skin surface treatment system generator
No Description
Aktina Corp.
12-210
In Commercial Distribution

  • B3651120008102 ()
  • B365122100 ()
  • B3651120008011 ()


  • Pulmonary function testing kit
Replacement Part
ESI CORPORATION
011B1263
In Commercial Distribution

  • B360011B12632 ()
  • B360011B12630 ()
  • B360011B12631 ()

  • Length: 14 Inch
011B1263

  • Basic intravenous administration set, noninvasive
The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorporates ergonomic and mechanical advantages for fluid injection in a variety of medical procedures.
ZIEN MEDICAL TECHNOLOGIES, INC.
PWR-10
Not in Commercial Distribution

  • B090PWR101 ()
  • B090PWR100 ()
  • B090PWR102 ()


  • Angiographic syringe
The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10-100-F
In Commercial Distribution

  • B090MT10100F1 ()
  • B090MT10100F0 ()
  • B090MT10100F2 ()
MT10-100-F

  • Thrombectomy tubing set, non-electronic
The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10-100
In Commercial Distribution

  • B090MT101000 ()
  • B090MT101001 ()
  • B090MT101002 ()
MT10-100

  • Thrombectomy tubing set, non-electronic
The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10
In Commercial Distribution

  • B090MT101 ()
  • B090MT100 ()
  • B090MT102 ()
MT10

  • Thrombectomy tubing set, non-electronic
The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
ZIEN MEDICAL TECHNOLOGIES, INC.
LR-N-059
In Commercial Distribution

  • B090LRN0591 ()
  • B090LRN0590 ()
  • B090LRN0592 ()

  • Catheter Working Length: 59 Centimeter
  • Introducer Sheath Compatibility: 7 French
LR-N-059

  • Intravascular occluding balloon catheter, image-guided
The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-S
In Commercial Distribution

  • B090E20130S1 ()
  • B090E20130S0 ()
  • B090E20130S2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
E20-130-S

  • Vascular microcatheter
The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-B
In Commercial Distribution

  • B090E20130B1 ()
  • B090E20130B0 ()
  • B090E20130B2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
E20-130-B

  • Vascular microcatheter
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-175-H
In Commercial Distribution

  • B090C35175H1 ()
  • B090C35175H0 ()
  • B090C35175H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 175 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-175-H

  • Vascular guide-catheter, single-use
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135-H
In Commercial Distribution

  • B090C35135H1 ()
  • B090C35135H0 ()
  • B090C35135H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 135 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-135-H

  • Vascular guide-catheter, single-use
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