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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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The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws.
CROSSROADS EXTREMITY SYSTEMS
MotoBAND CP, Non-Locking Screw, 3.5mm x 12mm
In Commercial Distribution

  • 00815432022625 ()

  • Length: 12 Millimeter
  • Outer Diameter: 3.5 Millimeter
130102

  • Stress-therapy vibroacoustic headband
No Description
You First Services, Inc.
GT35H
In Commercial Distribution

  • 00868536000433 ()


  • Plasma device disinfector
Iowa State fixation forceps, 3 3/8'', straight shafts, 1x2 teeth, flat 3-hole handle
AMBLER SURGICAL CORP.
Iowa State fixation forceps
In Commercial Distribution

  • 00190660204341 ()
9503E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
No Description
Medical Measurement Systems B.V.
G3-15
In Commercial Distribution

  • 08717775955115 ()


  • Gastroduodenal motility analysis system
No Description
Medical Measurement Systems B.V.
G3-10
In Commercial Distribution

  • 08717775955108 ()


  • Gastroduodenal motility analysis system
No Description
Medical Measurement Systems B.V.
G3-9
In Commercial Distribution

  • 08717775955092 ()


  • Gastroduodenal motility analysis system
No Description
Rst- Sanexas
RST-SANEXAS PT
In Commercial Distribution

  • 00860000214049 ()


  • Transcranial electrical stimulation system, pulsed-current
No Description
Rst- Sanexas
RST-SANEXAS Basic
In Commercial Distribution

  • 00860000214032 ()


  • Transcranial electrical stimulation system, pulsed-current
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.3
Not in Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.2
Not in Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
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