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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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CURO B3 Blood Pressure Monitor
KPI HEALTHCARE, INC.
CURO B3
In Commercial Distribution

  • 00860394001232 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
  • Blood glucose/blood pressure monitoring system, home-use
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose analyser IVD, home-use
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, point-of-care
  • Glucose monitoring system IVD, point-of-care
CURO L5 Cholesterol and Glucose measuring system
KPI HEALTHCARE, INC.
CURO L5 CURO L5
In Commercial Distribution

  • 00860394001225 ()


  • Multiple physiological parameter spot-check system analyser
  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care
  • Glucose analyser IVD, point-of-care
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, home-use
  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Supporting infection control, TwitchView™ utilizes a single-patient use Electrode Array. With the flexibility to secure to either left or right hand in seconds, the Electrode Array is easily adopted into the pre-surgical workflow. The one-piece, auto-centering design mitigates placement errors—a common cause of intra-operative system failure and measurement inaccuracies.
BLINK DEVICE COMPANY
Electrode v1
In Commercial Distribution

  • 00860298001086 ()
  • 00860298001055 ()


  • Neuromuscular transmission electrode
PTFE Non-absorbable Suture 18 inch in length, USP 6/0, Reverse Cutting Needle, 13mm, 3/8 curvature, Sterile
Golnit Sutures
mRD601338-45
In Commercial Distribution

  • 00860293000664 ()
  • 00860000584029 ()

  • 13mm 3/8 Circle Reverse Cutting Needle
  • USP 6/0 Suture Thread
  • Length: 18 Inch


  • Polytetrafluoroethylene suture
PTFE Non-absorbable Suture 18 inch in length, USP 4/0, Reverse Cutting Needle, 18mm, 3/8 curvature, Sterile
Golnit Sutures
mRD401853-45
In Commercial Distribution

  • 00860293000657 ()
  • 00860000584036 ()

  • Length: 18 Inch
  • USP 4/0 Suture Thread
  • 18mm 3/8 Circle Reverse Cutting Needle


  • Polytetrafluoroethylene suture
PTFE Non-absorbable Suture 18 inch in length, USP 4/0, Taper Point Needle, 13mm, 1/2 curvature, Sterile
Golnit Sutures
mTH401343-45
In Commercial Distribution

  • 00860293000640 ()
  • 00860000584005 ()

  • USP 4/0 Suture Thread
  • 13mm 1/2 Circle Taper Point Needle
  • Length: 18 Inch


  • Polytetrafluoroethylene suture
PTFE Non-absorbable Suture 18 inch in length, USP 5/0, Reverse Cutting Needle, 16mm, 3/8 curvature, Sterile
Golnit Sutures
mRD501643-45
In Commercial Distribution

  • 00860293000633 ()
  • 00860000584043 ()

  • Length: 18 Inch
  • USP 5/0 Suture Thread
  • 16mm, 3/8 Circle Reverse Cutting Needle


  • Polytetrafluoroethylene suture
PTFE Non-absorbable Suture 18 inch in length, USP 3/0, Reverse Cutting Needle, 19mm, 3/8 curvature, Sterile
Golnit Sutures
mRD301956-45
In Commercial Distribution

  • 00860293000626 ()
  • 00860000584012 ()

  • Length: 18 Inch
  • USP 3/0 Suture Thread
  • 19mm 3/8 Circle Reverse Cutting Needle


  • Polytetrafluoroethylene suture
PTFE Non-absorbable Suture 18 Inch in length, USP 5/0, Reverse Cutting Needle, 13mm, 3/8 curvature, Sterile
Golnit Sutures
mRD501343-45
In Commercial Distribution

  • 00860293000619 ()
  • 00860000584050 ()

  • Length: 18 Inch
  • USP 5/0 Suture Thread
  • 13mm 3/8 Circle Reverse Cutting Needle


  • Polytetrafluoroethylene suture
PTFE Non-absorbable Suture 18 inch in length, USP 4/0, Reverse Cutting Needle, 16mm, 3/8 curvature, Sterile
Golnit Sutures
mRD401648-45
In Commercial Distribution

  • 00860293000602 ()
  • 00860000584067 ()

  • USP 4/0 Suture Thread
  • 16mm 3/8 Circle Reverse Cutting Needle
  • Length: 18 Inch


  • Polytetrafluoroethylene suture
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