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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 Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
LABSTYLE INNOVATION LTD
1024-01
Not in Commercial Distribution

  • 00850065006017 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
LABSTYLE INNOVATION LTD
1015-01
In Commercial Distribution

  • 00850065006000 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
A tip kit containing 30 single-use laser tips intended for use with Biolase diode laser systems. The tips have the same core diameter of 300 microns and vary in length.
Biolase, Inc.
Perio EZ Tips Combo Pack, E3
In Commercial Distribution

  • 00647529001820 ()

  • Outer Diameter: 300 Micrometer
  • Length: 7 Millimeter
  • Length: 9 Millimeter
7400020

  • General/multiple surgical laser system beam guide, single-use, non-sterile
The VERIFY General Purpose EO Process Indicator Tape adheres to both natural and synthetic materials commonly used in sterile processing. They are used to identify processed packs from unprocessed packs.
STERIS CORPORATION
410100
Not in Commercial Distribution

  • 10724995044234 ()
  • 00724995044237 ()

  • Length: 60 Yard
  • Width: 1 Inch
410100

  • Sterilization packaging tape
The VERIFY General Purpose Steam Process Indicator Tape adheres to both natural and synthetic materials commonly used in sterile processing. They are used to identify processed packs from unprocessed packs.
STERIS CORPORATION
260010
Not in Commercial Distribution

  • 10724995044067 ()
  • 00724995044060 ()

  • Width: 1 Inch
  • Length: 60 Yard
260010

  • Sterilization packaging tape
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. . The fore foot and mid foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates. Also included are 2.7mm locking screws.
Ascension Orthopedics, Inc.
FFMFOOTIMP
Not in Commercial Distribution

  • M268FFMFOOTIMP1 ()
  • 10381780064633 ()
FFMFOOTIMP

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The fore foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates.
Ascension Orthopedics, Inc.
TFSFOREFTIMP
Not in Commercial Distribution

  • M268TFSFOREFTIMP1 ()
  • 10381780064589 ()
TFSFOREFTIMP

  • Internal orthopaedic fixation system, plate/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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