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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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NANOFIBER SOLUTIONS, INC.
FG-0051
In Commercial Distribution

  • 00852513007003 ()
FG-0051

  • Synthetic nanofiber barrier dressing
Tobra Graft Compressor with mesh filtration basket
Tobra Medical, Inc.
GC-100
In Commercial Distribution

  • 10852360007024 ()
  • 00852360007027 ()
GC-100

  • Orthopaedic surgery tissue debris collector, single-use
KEN_FLO NEEDLE FREE CONNECTOR
KENTRON HEALTHCARE, INC.
429000
In Commercial Distribution

  • 10852244007140 ()
  • 00852244007143 ()
429000

  • Positive-pressure intravenous line needleless valve-connector
Cup and Cone Reamer Implant System 12mm
FUSION ORTHOPEDICS, LLC
HT-60-1212-S
In Commercial Distribution

  • 00852164007988 ()
HT-60-1212-S

  • Bone-resection orthopaedic reamer, single-use
Cup and Cone Reamer Implant System 10mm
FUSION ORTHOPEDICS, LLC
HT-60-1010-S
In Commercial Distribution

  • 00852164007971 ()
HT-60-1010-S

  • Bone-resection orthopaedic reamer, single-use
Cup and Cone Reamer Implant System 8mm
FUSION ORTHOPEDICS, LLC
HT-60-0808-S
In Commercial Distribution

  • 00852164007964 ()
HT-60-0808-S

  • Bone-resection orthopaedic reamer, single-use
Removal Tool PEEK
FUSION ORTHOPEDICS, LLC
CD-HT-1000-S
In Commercial Distribution

  • 00852164007957 ()
CD-HT-1000-S

  • Screw-extraction orthopaedic reamer, single-use
HT Ti Sizer Wheel Titanium
FUSION ORTHOPEDICS, LLC
HT-TN-7050-S
In Commercial Distribution

  • 00852164007933 ()
HT-TN-7050-S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
HT Awl (Single)
FUSION ORTHOPEDICS, LLC
CD-09-6200-S
In Commercial Distribution

  • 00852164007926 ()
CD-09-6200-S

  • Screw-extraction orthopaedic reamer, single-use
PEEK Implant Instrument Kit Large
FUSION ORTHOPEDICS, LLC
HT-20-1150-S
In Commercial Distribution

  • 00852164007919 ()
HT-20-1150-S

  • Joint prosthesis implantation kit, single-use
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