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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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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
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