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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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A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.
N S SURGICAL COMPANY
08-007-18
In Commercial Distribution

  • G25008007180 ()

  • Length: 18 Centimeter
08-007-18

  • Spinal rongeur
The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisions. The instrument is used in conjunction with an A.M.I. TissueBag for retrieval of specimen bags. The A.M.I. Fascia Cutter Disposable Instrument allows for easy removal of specimens in order to avoid risk of damaging the specimen bag while enlarging the trocar incision.
AMI Agency for Medical Innovations GmbH
AFC 100
Not in Commercial Distribution

  • EAMIAFC1000 ()

  • Outer Diameter: 13 Millimeter
  • Length: 195 Millimeter
AFC 100

  • Scalpel, single-use
Sickbay Clinical Platform is a software product that is intended to run on hospital servers on a hospital’s secure network. It gathers and stores all the physiological sensor data from patients admitted to the ER or ICU and is capable of re-displaying all the physiological sensor data in real-time when gathered or at any later time. The Sickbay Clinical Platform can be thought of as three distinct subsystems working together. The first subsystem is called the Sickbay Informatics server. This component does most of the work involving acquisition and archiving physiological data, executing data processing and data management functionality, and serving data on request to clients. The second component of sickbay is a database. The database is used to organize all of the relationships between data on the sickbay system. The third component of the Sickbay Clinical Platform is a web-server used for data visualization.
Medical Informatics Corp.
3.1.20.
In Commercial Distribution

  • B693SICKBAY0301200 ()


  • Medical equipment clinical data interfacing software
Dent Zar’s Z-Bond is a One-Step Light-Cured Self-Etching Dentin/Enamel Bonding Adhesive, which releases fluorides and does not require mixing, because the adhesive combines properties of etching and bonding in a single bottle. The result is fast and saves chair time. Z-Bond markedly reduces sensitivity due to the fact that the adhesive penetrates the smear layer and adheres to the tooth structure without opening tubules. The work effort is significantly reduced and simplified with Z Bond. All adhesive treatment steps are included in one component. Z Bond is a 7th generation of bonding dentin/enamel adhesives. Z Bond is designed to promote adhesion to tooth structure in the following applications:
DENT ZAR, INC.
0021
In Commercial Distribution

  • D83600210 ()
0021

  • Dentine bonding agent/set
On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (not included) weighing 3 ounces to 4 pounds (90-1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing the bag on the arm of the valve. Immediate oxygen flow is provided when bag is lifted from the arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 3000-RS
In Commercial Distribution

  • M996BE3000RS0 ()
BE 3000-RS

  • Respiratory gas output switch
On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (not included) weighing 3 ounces to 4 pounds (90-1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing the bag on the arm of the valve. Immediate oxygen flow is provided when bag is lifted from the arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 3000-RA
In Commercial Distribution

  • M996BE3000RA0 ()
BE 3000-RA

  • Respiratory gas output switch
On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (not included) weighing 3 ounces to 4 pounds (90-1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing the bag on the arm of the valve. Immediate oxygen flow is provided when bag is lifted from the arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 3000-PS
In Commercial Distribution

  • M996BE3000PS0 ()
BE 3000-PS

  • Respiratory gas output switch
On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (not included) weighing 3 ounces to 4 pounds (90-1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing the bag on the arm of the valve. Immediate oxygen flow is provided when bag is lifted from the arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 3000-PA
In Commercial Distribution

  • M996BE3000PA0 ()
BE 3000-Pa

  • Respiratory gas output switch
On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (not included) weighing 3 ounces to 4 pounds (90-1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing the bag on the arm of the valve. Immediate oxygen flow is provided when bag is lifted from the arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 3000-FS
In Commercial Distribution

  • M996BE3000FS0 ()
BE 3000-FS

  • Respiratory gas output switch
On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (not included) weighing 3 ounces to 4 pounds (90-1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing the bag on the arm of the valve. Immediate oxygen flow is provided when bag is lifted from the arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 3000-FA
In Commercial Distribution

  • M996BE3000FA0 ()
BE 3000-FA

  • Respiratory gas output switch
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