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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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Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
Peak low and FEV1 meter
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One USA
In Commercial Distribution

  • 08052990321681 ()


  • Expiratory peak flow meter, digital
Articulated arm
Jeisys Medical Inc.
Edge ONE Arm
In Commercial Distribution

  • 08800020110022 ()


  • Dermatological carbon dioxide laser system
Unlocker for use with the CarboClear Pedicle Screw System.
CARBOFIX ORTHOPEDICS LTD
Unlocker - One Piece
In Commercial Distribution

  • 07290110204648 ()
PPS922781

  • Orthopaedic inorganic implant inserter/extractor, reusable
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321308 ()
  • 00850065321301 ()
CE-A90A(White)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321292 ()
  • 00850065321295 ()
CE-A90A(Black)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321261 ()
  • 00850065321264 ()
CE-A90A(skin)

  • Air-conduction hearing aid, in-the-ear
Femoral Spacer Block - One Side -25mm
B-ONE ORTHO, CORP.
8829P00027
In Commercial Distribution

  • 00843575112446 ()
8829P00027

  • Orthopaedic implant/instrument assembling device
Femoral Spacer Block - One Side -22mm
B-ONE ORTHO, CORP.
8829P00026
In Commercial Distribution

  • 00843575112439 ()
8829P00026

  • Orthopaedic implant/instrument assembling device
Femoral Spacer Block - One Side -19mm
B-ONE ORTHO, CORP.
8829P00025
In Commercial Distribution

  • 00843575112422 ()
8829P00025

  • Orthopaedic implant/instrument assembling device
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