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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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(not in use)
FUSION ORTHOPEDICS, LLC
TN-AK-4020
In Commercial Distribution

  • 00840124506046 ()
TN-AK-4020

  • Surgical tamp, reusable
No Description
CITIEFFE SRL
Fracture alignment guide wire exchange tool
In Commercial Distribution

  • 08059386742501 ()
EBA-5306

  • Orthopaedic bone-fragment manipulator, reusable
The SG 066 Oxygen Enrichment Kit is designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 066
In Commercial Distribution

  • M996SG0660 ()


  • Oxygen administration enhancement device
Avid IF2 INTERFERENTIAL STIMULATION SYSTEM
Vision Quest Industries Incorporated
AV-IF19A
In Commercial Distribution

  • 00817717021811 ()


  • Interferential electrical stimulation system
No Description
WEXLER SURGICAL, INC.
AL1031.1
Not in Commercial Distribution

  • M944AL103110 ()
  • 00840240907574 ()


  • Valvulotome
No Description
WEXLER SURGICAL, INC.
AL1030.1
Not in Commercial Distribution

  • M944AL103010 ()
  • 00840240907567 ()


  • Valvulotome
(not in use)
FUSION ORTHOPEDICS, LLC
TN-DB-3050
In Commercial Distribution

  • 00819034025398 ()
TN-DB-3050

  • Surgical tamp, reusable
(not in use)
FUSION ORTHOPEDICS, LLC
TN-DB-2050
In Commercial Distribution

  • 00819034025381 ()
TN-DB-2050

  • Surgical tamp, reusable
Patient use, Non-invasive, Central Neuromodulation Smart Device
ENEURA, INC.,
DWG-0601
In Commercial Distribution

  • 00816140020132 ()


  • Home-use magnetic neural stimulator
Transcranial Magnetic Stimulator Device
ENEURA, INC.,
DWG-0501-SG
In Commercial Distribution

  • 00816140020125 ()
DWG-0501-SG

  • Home-use magnetic neural stimulator
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