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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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Lung Preservation System
Traferox Technologies Inc
909-0011
In Commercial Distribution

  • 07540161670153 ()


  • General-purpose donor-organ preservation/transport system
No Description
Biomet Orthopedics, LLC
14-440043
In Commercial Distribution

  • 00887868093258 ()
14-440043

  • Fluted surgical drill bit, single-use
No Description
Biomet Orthopedics, LLC
14-440041
In Commercial Distribution

  • 00887868093234 ()
14-440041

  • Cannulated surgical drill bit, single-use
No Description
Biomet Orthopedics, LLC
14-401441
In Commercial Distribution

  • 00887868091742 ()
14-401441

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
14-401440
In Commercial Distribution

  • 00887868091629 ()
14-401440

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
06259
In Commercial Distribution

  • 00887868083631 ()
06259

  • External orthopaedic fixation system, single-use
No Description
INTERVENTIONAL SPINE, INC
6190-02
Not in Commercial Distribution

  • 81195401219900 ()
6190-02

  • Orthopaedic joint/limb rongeur
No Description
INTERVENTIONAL SPINE, INC
6190-01
Not in Commercial Distribution

  • 81195401218224 ()
6190-01

  • Orthopaedic joint/limb rongeur
Human lymphocytes for 12 detections of human HLA-DR/DQ antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823350
Not in Commercial Distribution

  • 07611969952946 ()
823350

  • HLA class II antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXMK1140
In Commercial Distribution

  • 57460691952824 ()
  • 07460691952829 ()

  • Total Volume: 3.0000 Milliliter
PXMK1140

  • Invasive-pressure external transducer, single-use
8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B35400 ()
  • B354CCS8169 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B35400 ()
  • B354CCS8165 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B35400 ()
  • B354CCS8164 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B35400 ()
  • B354CCS8162 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B354CCS8160 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
5mm x 10mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS510
In Commercial Distribution

  • B35400 ()
  • B354CCS5109 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
5mm x 10mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS510
In Commercial Distribution

  • B35400 ()
  • B354CCS5105 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
5mm x 10mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS510
In Commercial Distribution

  • B35400 ()
  • B354CCS5103 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
5mm x 10mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS510
In Commercial Distribution

  • B35400 ()
  • B354CCS5102 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B35400 ()
  • B354CCS8163 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
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