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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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GUIDE PIN 3.2mm x 330mm - 00848665000009

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S0100-000
In Commercial Distribution

  • 00848665000009 ()


  • Orthopaedic bone wire

PosiSep X2 0.8" x 2.3" - 00858439001903

PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210615
In Commercial Distribution

  • 00858439001910 ()
  • 00858439001903 ()

  • Width: 0.8 Inch
  • Length: 2.3 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable

PosiSep X2 0.7" x 1.7" - 00858439001880

PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210614
In Commercial Distribution

  • 00858439001880 ()
  • 00858439001897 ()

  • Width: 0.7 Inch
  • Length: 1.7 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable

PosiSep C 0.6 x 2.0 - 00858439001675

PosiSep C 0.6 x 2.0 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C 0.6 x 2.0 devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
HEMOSTASIS, LLC
9210854
In Commercial Distribution

  • 00858439001682 ()
  • 00858439001675 ()

  • Width: .64 Inch
  • Length: 2.0 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived

TWIST DRILL 3.2MM X 280MM - 00880304385382

No Description
Biomet Orthopedics, LLC
472370
In Commercial Distribution

  • 00880304385382 ()
472370

  • Fluted surgical drill bit, reusable

T-HANDLE REAMER 5.0MM X 30CM - 00880304383067

No Description
Biomet Orthopedics, LLC
471338
In Commercial Distribution

  • 00880304383067 ()
471338

  • Medullary canal orthopaedic reamer, rigid

T-HANDLE REAMER 4.5MM X 30CM - 00880304383050

No Description
Biomet Orthopedics, LLC
471336
In Commercial Distribution

  • 00880304383050 ()
471336

  • Medullary canal orthopaedic reamer, rigid

T-HANDLE REAMER 4.0MM X 30CM - 00880304383043

No Description
Biomet Orthopedics, LLC
471334
In Commercial Distribution

  • 00880304383043 ()
471334

  • Medullary canal orthopaedic reamer, rigid

T-HANDLE REAMER 3.0MM X 30CM - 00880304383029

No Description
Biomet Orthopedics, LLC
471330
In Commercial Distribution

  • 00880304383029 ()
471330

  • Medullary canal orthopaedic reamer, rigid

CALIBRATED DRILL 4.3MM X 365MM - 00880304489110

No Description
Biomet Orthopedics, LLC
27961
In Commercial Distribution

  • 00880304489110 ()
27961

  • Fluted surgical drill bit, single-use
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