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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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and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
8 Fr
In Commercial Distribution

  • 10860000931332 ()
  • 00860000931335 ()

  • Catheter Gauge: 8 French
  • 8 FR (3.3mm)X 32”(80cm)
GFTB 508

  • Nasogastric feeding tube
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00150
Not in Commercial Distribution

  • 00873263001509 ()
FC1008

  • Neurosurgical micro targeting drive
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00144
Not in Commercial Distribution

  • 00873263001448 ()
FC1008

  • Neurosurgical micro targeting drive
microTargeting Controller with encoder option for use with STar and mT Drives
FHC, INC.
FC1007-00143
In Commercial Distribution

  • 00873263001431 ()
FC1007

  • Neurosurgical micro targeting drive
The MRI Stretcher with Fowler positioning is non-magnetic, all aluminum, and designed for heavy-duty use.
Mirion Technologies (capintec), Inc.
240-110
In Commercial Distribution

  • 00879942070767 ()
240-110

  • MRI system table, non-powered
Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring
PROSOMNUS SLEEP TECHNOLOGIES
IA Monogram Monitor
In Commercial Distribution

  • 00863039000430 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Tracheostomy Care Tray with Gloves, Sterile
Dynarex Corporation
14001
In Commercial Distribution

  • 00860008059567 ()
  • 00860008123244 ()


  • Tracheostomy tube neck holder, reusable
The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
C9866
In Commercial Distribution

  • 05712821006448 ()
  • 05712821006431 ()


  • Surgical torque wrench, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0218-200
In Commercial Distribution

  • 00848665040128 ()


  • Bone awl, reusable
No Description
MAXILL, INC.
6070541128
In Commercial Distribution

  • D89260705411282 ()
  • D89260705411281 ()
  • D89260705411283 ()
  • D89260705411280 ()


  • Dental floss
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