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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
iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software
iotaSOFT Plus Drive Unit
Iotamotion, Inc.
IM-05
In Commercial Distribution

  • 00850002960068 ()


  • Robotic surgical system application software
Pediatric Laparotomy Drape II with Armboard Covers
O&M HALYARD, INC.
48076
In Commercial Distribution

  • 30680651480768 ()
  • 10680651480764 ()
48076

  • Cardiac mapping system application software
Trocar Procedure Kit, Lap Chole
Conmed Corporation
CD7571M
Not in Commercial Distribution

  • 10653405055631 ()
  • 20653405055638 ()
  • 00653405055634 ()

  • 5-12 Millimeter Outer Diameter ENTREE II Valve/Reducer
  • Length: 110 Millimeter
  • Outer Diameter: 10 Millimeter
  • Outer Diameter: 5 Millimeter
CD7571M

  • Cardiology information system application software
Trocar Procedure Kit, Lap Appy
Conmed Corporation
CD7570M
Not in Commercial Distribution

  • 10653405055624 ()
  • 20653405055621 ()
  • 00653405055627 ()

  • 10/12 Millimeter Outer Diameter Core Audible Dilating Trocar
  • Outer Diameter: 5 Millimeter
  • 5-12 Millimeter Outer Diameter ENTREE II Valve/Reducer
CD7570M

  • Cardiology information system application software
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
86002
In Commercial Distribution

  • 07290014064089 ()


  • Posterior lumbar spine prosthesis
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