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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 Model 2740S&C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.
Inspire Medical Systems, Inc.
900-026-001
In Commercial Distribution

  • 00810098650311 ()
2740S&C

  • Implantable sleep apnoea treatment system, respiration-sensing
The NeuroPace® Patient Data Management System (PDMS), part of the NeuroPace® RNS® System, is used to store and provide access to historical RNS® Neurostimulator and patient data. The PDMS can also be used to create and simulate detection settings that can be sent to a user identified NeuroPace® Programmer for use at a later date. PDMS is stand-alone software that is accessible via secure internet connection.
Neuropace, Inc.
Model 4340
In Commercial Distribution

  • 00855547005007 ()


  • Cannulated surgical drill bit, reusable
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System. The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader data and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.
Endotronix, Inc.
100543-00
In Commercial Distribution

  • 00850008997051 ()


  • Implantable pulmonary artery pressure monitoring system
The SpineSeal Spine Sealant is indicated as an adjuct to sutured dural repair during spine surgery to provide a watertight closure.
Pramand LLC
SS-2055
In Commercial Distribution

  • 20860010683723 ()
  • 00860010683729 ()
SS-2055

  • Dura mater sealant
FemCap™ is indicated for use by women of child-bearing age who desire a barrier device to prevent or postpone pregnancy.
FEMCAP, INC.
30 mm large
In Commercial Distribution

  • 00863008000126 ()

  • 30 mm
70-399-30

  • Contraceptive cervical cap, reusable
FemCap™ is indicated for use by women of child-bearing age who desire a barrier device to prevent or postpone pregnancy.
FEMCAP, INC.
26 mm medium
In Commercial Distribution

  • 00863008000119 ()

  • 26 mm
70-399-26

  • Contraceptive cervical cap, reusable
FemCap™ is indicated for use by women of child-bearing age who desire a barrier device to prevent or postpone pregnancy.
FEMCAP, INC.
22 mm small
In Commercial Distribution

  • 00863008000102 ()

  • 22 mm
70-399-22

  • Contraceptive cervical cap, reusable
Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Selenia® Dimensions® digital mammography system.
Hologic, Inc.
ASY-11748-2D
In Commercial Distribution

  • 15420045510388 ()
ASY-11748-2D

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Selenia® Dimensions® digital mammography system.
Hologic, Inc.
ASY-11748-2D-V20
In Commercial Distribution

  • 15420045518049 ()
ASY-11748-2D-V20

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Selenia® Dimensions® digital mammography system.
Hologic, Inc.
ASY-11748-2D-V2.1
In Commercial Distribution

  • 15420045518032 ()
ASY-11748-2D-V2.1

  • Stationary mammographic x-ray system, digital
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