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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 Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems. The measurement principle is the ultrasound transit-time method. The medical use of the device is appropriate in the following extracorporeal procedures: - Cardio-pulmonary bypass, membrane-oxygenation, hemodialysis, hemofiltration, plasmapheresis - Perfusion, infusion, transfusion - Several shunt-applications
em-tec GmbH
11945
In Commercial Distribution

  • 04062114000280 ()
11945

  • Noninvasive vascular ultrasound system, line-powered
The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems. The measurement principle is the ultrasound transit-time method. The medical use of the device is appropriate in the following extracorporeal procedures: - Cardio-pulmonary bypass, membrane-oxygenation, hemodialysis, hemofiltration, plasmapheresis - Perfusion, infusion, transfusion - Several shunt-applications
em-tec GmbH
11923
In Commercial Distribution

  • 04062114000266 ()
11923

  • Noninvasive vascular ultrasound system, line-powered
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVMNS
In Commercial Distribution

  • B201CGVMNS0 ()
  • B201CGVMNS1 ()
  • B201CGVMNS3 ()
  • B201CGVMNS2 ()
CG-VM-NS

  • Imaging lesion localization marker, external, single-use
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM2NS
In Commercial Distribution

  • B201CGVM2NS0 ()
  • B201CGVM2NS1 ()
  • B201CGVM2NS3 ()
  • B201CGVM2NS2 ()
CG-VM2-NS

  • Imaging lesion localization marker, external, single-use
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM2
In Commercial Distribution

  • B201CGVM20 ()
  • B201CGVM21 ()
  • B201CGVM23 ()
  • B201CGVM22 ()
CG-VM2

  • Imaging lesion localization marker, external, single-use
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM
In Commercial Distribution

  • B201CGVM2 ()
  • B201CGVM1 ()
  • B201CGVM0 ()
  • B201CGVM3 ()


  • Imaging lesion localization marker, external, single-use
The Capture Screw System is comprised of Low Profile screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The low profile, cannulated screw is a cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0, and 4.0mm diameters with lengths of 6 – 50mm. The system includes instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
CAPLOPROIMP
Not in Commercial Distribution

  • M268CAPLOPROIMP1 ()
  • 10381780064527 ()
CAPLOPROIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample.
Shenzhen Yuwen E-Commerce Co., Ltd.
TS1111011
In Commercial Distribution

  • 16971292001437 ()
  • 06971292001430 ()
  • 06971292001133 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample.
Shenzhen Yuwen E-Commerce Co., Ltd.
TS1500011
In Commercial Distribution

  • 16971292001291 ()
  • 06971292001287 ()
  • 06971292001270 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample.
Shenzhen Yuwen E-Commerce Co., Ltd.
TS1150011
In Commercial Distribution

  • 16971292001246 ()
  • 06971292001256 ()
  • 06971292001218 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
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