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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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No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A20121 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A20081 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A20041 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A15201 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A15121 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A15081 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A15041 ()
4100A1504

  • Coronary angioplasty balloon catheter, basic
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
ShangRing Male Circumcision Device Self-locking
Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
A
In Commercial Distribution

  • 26939550822368 ()
  • 16939550822361 ()
  • 86939550822360 ()


  • Surgical penis clamp, single-use
Adult SpO2 Sensor Two Piece
Covidien LP
A
In Commercial Distribution

  • 10884522042123 ()
  • 20884522042120 ()

  • Patient Weight, >30, KG;


  • Transcutaneous blood gas monitor sensor
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