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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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Mandible Reconstruction kit
Materialise NV
SD980.031
In Commercial Distribution

  • 05420060380754 ()
SD980.031

  • Custom-made organ/bone anatomy model/surgical guide kit
Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide
The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.
BERTEC CORPORATION
97P-0036
In Commercial Distribution

  • 00850017250079 ()


  • Posturography system platform
Alert Display Driver (ADD) - Configuration 2 (curved)
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-2
Not in Commercial Distribution

  • 00850016398024 ()
D-ADD-X-2

  • Nurse call system
Alert Display Driver (ADD) - Configuration 1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-1
Not in Commercial Distribution

  • 00850016398017 ()
D-ADD-X-1

  • Nurse call system
Driver, T6 Torx X15TN SS
Accufix Surgical, Inc.
AJDH-T6-X15TN
In Commercial Distribution

  • 00850044114009 ()
AJDH-T6-X15TN

  • Surgical screwdriver, reusable
DriverClip NBM. Clip recess underside of finger dental implant screwdriver with floss tether attachment. Resilient slide lock. Single use.
Implantwise LLC
NBM.
In Commercial Distribution

  • 00850043387367 ()


  • Surgical instrument interim-placement holder, single-use
DriverClip S. Clip recess underside of finger dental implant screwdriver with floss tether attachment. Single use only.
Implantwise LLC
S
In Commercial Distribution

  • 00850043387350 ()


  • Surgical instrument interim-placement holder, single-use
DriverClip Universal. Clip that goes through any orifice of a dental implant screwdriver with a floss tether attachment. Single use only.
Implantwise LLC
Universal
In Commercial Distribution

  • 00850043387343 ()


  • Surgical instrument interim-placement holder, single-use
GLOBUS EXCELSIUS GPS DRIVER BUSHING FOR 2.7MM AND 3.2MM DRILL, OVERALL LENGTH 46.5MM
PMT CORPORATION
2103-229
In Commercial Distribution

  • 00650551004905 ()


  • Neurological stereotactic surgery system
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