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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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Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100020-75100
In Commercial Distribution

  • B4671000207510055 ()
  • B46710002075100 ()
  • B467100020751004 ()
ACG32

  • Haemodialysis concentrate
Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100015-75200
In Commercial Distribution

  • B467100015752004 ()
  • B46710001575200 ()
  • B4671000157520055 ()
ACG2

  • Haemodialysis concentrate
Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100000-75100
In Commercial Distribution

  • B467100000751004 ()
  • B46710000075100 ()
  • B4671000007510055 ()
ACD15-ACG30

  • Haemodialysis concentrate
Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
SPN-1005
In Commercial Distribution

  • B090SPN10051 ()
  • B090SPN10050 ()
  • B090SPN10052 ()
SPN-1005

  • Torque manipulation device
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.50-065
In Commercial Distribution

  • B090S6500651 ()
  • B090S6500650 ()
  • B090S6500652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.50mm
S6.50-065

  • Peripheral angioplasty balloon catheter, basic
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.25-065
In Commercial Distribution

  • B090S6250650 ()
  • B090S6250651 ()
  • B090S6250652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.25mm
S6.25-065

  • Peripheral angioplasty balloon catheter, basic
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
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.
MT10-100-3
In Commercial Distribution

  • B090MT1010031 ()
  • B090MT1010030 ()
  • B090MT1010032 ()
MT10-100-3

  • 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
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