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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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Integra® Jarit® Hoen Periosteal Elevator
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
285360
In Commercial Distribution

  • M2742853601 ()
  • 10381780456247 ()
285-360

  • Neurosurgical bone flap elevator
Integra® Jarit® Love-Adson Periosteal Elevator, Curved
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
285355
In Commercial Distribution

  • M2742853551 ()
  • 10381780456230 ()
285-355

  • Neurosurgical bone flap elevator
Integra® Miltex® Langenbeck Periosteal Elevator, 7-3/4", 17mm Wide Blade, Sharp
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH26-1412
In Commercial Distribution

  • H834MH2614120 ()
  • 10381780487982 ()
MH26-1412

  • Neurosurgical bone flap elevator
A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a single-use device.
MEED SKILL SURGICAL
MSS71023A
In Commercial Distribution

  • G429MSS71023A0 ()
MSS71023A

  • Dressing/utility forceps, tweezers-like, single-use
Lane Dressing forceps with 1x2 teeth is a surgical instrument.
CONCISE ENTERPRISES
150402614
In Commercial Distribution

  • G202150402614 ()
15-04026-14

  • Dressing/utility forceps, tweezers-like, single-use
Adson forceps are a type of surgical instrument commonly used in medical procedures. The forceps are named after Alfred Washington Adson, a prominent American surgeon who invented them in the early 20th century. The Adson forceps are specifically designed for delicate surgical procedures that require a precise grip and manipulation of small tissues, such as skin or blood vessels. They are fine-tipped and have a serrated pattern on the working end that provides a firm grip on the tissue being held. The forceps are made of high-quality stainless steel and are approximately 12.5cm in length. They feature a hinged design with a spring mechanism that allows the surgeon to easily manipulate the forceps with one hand. Overall, the Adson forceps are a valuable tool in any surgical setting and are commonly used in various procedures such as plastic surgery, dermatology, and ophthalmology. Their fine tips and delicate grip make them an ideal choice for precise and delicate surgical procedures.
CONCISE ENTERPRISES
150283412
In Commercial Distribution

  • G2021502834120 ()
15-02834-12

  • Dressing/utility forceps, tweezers-like, single-use
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
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.
v1.2
Not in Commercial Distribution

  • B553WELLDOCRX120 ()


  • Home pharmaceutical management support software
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