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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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A sterile device inserted through a compatible flexible endoscope to aid in implanting a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is commonly made of polytetrafluoroethylene (PTFE). This is a single-use device.
HOBBS MEDICAL, INC.
6138
In Commercial Distribution

  • M84961380 ()
6138

  • Endoscopic stent-placement system
A sterile device inserted through a compatible flexible endoscope to aid in implanting a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is commonly made of polytetrafluoroethylene (PTFE). This is a single-use device.
HOBBS MEDICAL, INC.
6136
In Commercial Distribution

  • M84961360 ()
6136

  • Endoscopic stent-placement system
A sterile device inserted through a compatible flexible endoscope to aid in implanting a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is commonly made of polytetrafluoroethylene (PTFE). This is a single-use device.
HOBBS MEDICAL, INC.
6134
In Commercial Distribution

  • M84961340 ()
6134

  • Endoscopic stent-placement system
A sterile device inserted through a compatible flexible endoscope to aid in implanting a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is commonly made of polytetrafluoroethylene (PTFE). This is a single-use device.
HOBBS MEDICAL, INC.
6132
In Commercial Distribution

  • M84961320 ()
6132

  • Endoscopic stent-placement system
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 Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location.
ABAXIS, INC.
400-0037
In Commercial Distribution

  • EABA40000371 ()
  • EABA40000370 ()
400-0037

  • Lactate IVD, reagent
  • Magnesium (Mg2+) IVD, reagent
  • Inorganic phosphate (PO43-) IVD, reagent
  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Albumin IVD, reagent
  • Glucose IVD, reagent
The Lipoprint System LDL Subfractions Kit is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions from VLDL to HDL) in fasting serum or plasma with a Total Cholesterol concentration of >100mg/dL. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment, and clinical evaluation.
QUANTIMETRIX CORPORATION
48-7002
In Commercial Distribution

  • M05148700215 ()
  • 00896863002332 ()
48-7002

  • Total lipoprotein IVD, control
STOMA® titanium bone screws Ø1,3 X 10mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. STOMA® titanium bone screws are delivered in non-sterile conditions.
Storz am Mark GmbH
23053.10
In Commercial Distribution

  • ESAM23053101 ()
  • ESAM23053100 ()

  • Outer Diameter: 1.3 Millimeter
  • Length: 10 Millimeter
23053.10

  • Craniofacial bone screw, non-bioabsorbable
STOMA® titanium bone screws Ø1,3 X 8mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. STOMA® titanium bone screws are delivered in non-sterile conditions.
Storz am Mark GmbH
23053.08
In Commercial Distribution

  • ESAM23053081 ()
  • ESAM23053080 ()

  • Length: 8 Millimeter
  • Outer Diameter: 1.3 Millimeter
23053.08

  • Craniofacial bone screw, non-bioabsorbable
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