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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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40mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD4
In Commercial Distribution

  • 1111094 ()
  • M364111109FD40 ()

  • Outer Diameter: 9 Millimeter
  • Length: 40 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
35mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD3
In Commercial Distribution

  • 1111093 ()
  • M364111109FD30 ()

  • Outer Diameter: 9 Millimeter
  • Length: 35 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
30mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD2
In Commercial Distribution

  • M364111109FD20 ()
  • 1111092 ()

  • Length: 30 Millimeter
  • Outer Diameter: 9 Millimeter
11-1109-FD2

  • Sacroiliac joint intra-articular arthrodesis implant
25mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD1
In Commercial Distribution

  • M364111109FD10 ()
  • 1111091 ()

  • Length: 25 Millimeter
  • Outer Diameter: 9 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
Holter Server Analyzer
Lifesignals, Inc.
UA2251-SA
In Commercial Distribution

  • B353UA2251SA1 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Desktop Analyzer
Lifesignals, Inc.
UA2251-DA
In Commercial Distribution

  • B353UA2251DA1 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482080 ()
CCZ1205048208

  • Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482050 ()
CCZ1205048205

  • Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482030 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Automated microscope system for immunofluorescent determination of autoantibodies.
IMMUNO CONCEPTS INC
IN220
In Commercial Distribution

  • M74900IN2201 ()
IN220

  • Cell morphology analyser IVD, automated/semi-automated
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