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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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SCHOLTEN SURGICAL INSTRUMENTS, INC.
SU101-50
In Commercial Distribution

  • 00866215000002 ()


  • Endomyocardial biopsy forceps, single-use
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
HT Sizer Wheel PEEK
FUSION ORTHOPEDICS, LLC
TN-05-7010-S
In Commercial Distribution

  • 00852164007902 ()
TN-05-7010-S

  • Surgical implant/trial-implant/sizer holder, single-use
Sizer Rod Packaging (00850017962620, 00850017962637, 00850017962644)
SUBCHONDRAL SOLUTIONS, INC.
6810
In Commercial Distribution

  • 10850017962658 ()
  • 00850017962651 ()
6810

  • Surgical implant/trial-implant/sizer holder, single-use
Sizer, 9mm/10mm
SUBCHONDRAL SOLUTIONS, INC.
10-0910
In Commercial Distribution

  • 00850017962644 ()

  • Lumen/Inner Diameter: 9 Millimeter
  • Lumen/Inner Diameter: 10 Millimeter
10-0910

  • Surgical implant/trial-implant/sizer holder, single-use
Sizer, 7mm/8mm
SUBCHONDRAL SOLUTIONS, INC.
10-0708
In Commercial Distribution

  • 00850017962637 ()

  • Lumen/Inner Diameter: 7 Millimeter
  • Lumen/Inner Diameter: 8 Millimeter
10-0708

  • Surgical implant/trial-implant/sizer holder, single-use
Sizer, 5mm/6 mm
SUBCHONDRAL SOLUTIONS, INC.
10-0506
In Commercial Distribution

  • 00850017962620 ()

  • Lumen/Inner Diameter: 5 Millimeter
  • Lumen/Inner Diameter: 6 Millimeter
10-0506

  • Surgical implant/trial-implant/sizer holder, single-use
Endomycardial Biopsy Forceps
ST. JUDE MEDICAL, INC.
408299
In Commercial Distribution

  • 05415067009579 ()

  • Length: 105 Centimeter
  • Catheter Gauge: 7 French
408299

  • Endomyocardial biopsy forceps, single-use
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