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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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ECONO STERILE CEMENT SPATULA #24 STRL CS/25
SKLAR CORPORATION
96-2245M
In Commercial Distribution

  • 50649111448612 ()
  • 10649111448614 ()


  • Orthopaedic cement spatula
ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25
SKLAR CORPORATION
96-2534
In Commercial Distribution

  • 50649111478817 ()
  • 10649111478819 ()


  • Dressing/utility forceps, tweezers-like, single-use
No Description
American Medicals
1
In Commercial Distribution

  • B356111PL86414ST0 ()
  • B356111PL86414ST1 ()


  • General surgery wound probe/packer
ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25
SKLAR CORPORATION
96-2412
In Commercial Distribution

  • 50649111035867 ()
  • 10649111035869 ()


  • Dressing/utility forceps, tweezers-like, single-use
ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50
SKLAR CORPORATION
96-2410
In Commercial Distribution

  • 50649111035669 ()
  • 10649111035661 ()


  • Dressing/utility forceps, tweezers-like, single-use
ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25
SKLAR CORPORATION
96-2412M
In Commercial Distribution

  • 50649111027015 ()
  • 10649111027017 ()


  • Dressing/utility forceps, tweezers-like, single-use
VENTERA SINUS DILATION BALLOON 1-PACK
Smith & Nephew, Inc.
650-60100S
Not in Commercial Distribution

  • 00817470009729 ()
650-60100S

  • Nasal/paranasal balloon catheter
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
v2.0
Not in Commercial Distribution

  • B553WELLDOCRX200 ()


  • Home pharmaceutical management support software
Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value. Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
v1.4
Not in Commercial Distribution

  • B553WELLDOCRX140 ()


  • Home pharmaceutical management support software
Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value. Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
v1.3
In Commercial Distribution

  • B553WELLDOCRX130 ()


  • Home pharmaceutical management support software
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