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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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AIR-FLOW MASTER
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353002749 ()
FT-185HF/HF

  • Dental abrasive air jet system
AIR-FLOW S1
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353002701 ()
FT-177HF/HF

  • Dental abrasive air jet system
AIR-FLOW System White
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353002695 ()
FS-305HF/C

  • Dental abrasive air jet system
The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at the time of surgery. This bone model is a 1-to-1 representation of a specific patient's bony anatomy. The SmartBone is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
A
Not in Commercial Distribution

  • 00811813020235 ()

  • Patient-specific
0006-0007-UPI

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The PowerCube Body+ and Diffusion+ include an extra-large body plethysmography chamber.
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365501247 ()


  • Pulmonary function analysis system, adult
The PowerCube Body+ include an extra-large body plethysmography chamber.
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365501230 ()


  • Pulmonary function analysis system, adult
The PowerCube Body+ and Diffusion+ include a wheelchair-accessible body plethysmography chamber.
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365501223 ()


  • Pulmonary function analysis system, adult
The PowerCube Body+ include a wheelchair body plethysmography chamber with a door that opens to the right.
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365501216 ()


  • Pulmonary function analysis system, adult
The PowerCube Body+ / Diffusion+ include a standard body plethysmography chamber with a door that opens to the right and bench seating.
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365501209 ()


  • Pulmonary function analysis system, adult
The PowerCube Body+ include a standard Body Plethmography chamber with a door that opens to the right and bench seating.
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365501193 ()


  • Pulmonary function analysis system, adult
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