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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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Multi-functional shaver blade, disposable
RELIGN CORPORATION
R-10008
In Commercial Distribution

  • 10859273007080 ()
  • 00859273007083 ()

  • Outer Diameter: 4.2 Millimeter
R-10008

  • Orthopaedic bur, single-use
  • Endoscopic electrosurgical electrode, bipolar, single-use
  • Arthroscopic shaver system blade, single-use
Shaver Handpiece
RELIGN CORPORATION
R-10002
Not in Commercial Distribution

  • 00859273007021 ()
R-10002

  • Arthroscopic shaver system handpiece, electrically-powered
System Controller with Footswitch
RELIGN CORPORATION
R-10001
In Commercial Distribution

  • 00859273007014 ()
R-10001

  • Arthroscopic shaver/electrosurgical system generator
IVC-THREE Blastocyst Medium is a synthetic, defined culture medium composed of a balanced mixture of salts, amino acid, vitamins and other nutrients designed to support embryo growth and blastocyst development in vitro. IVC-THREE Blastocyst Medium has been formulated without phosphate, which may be detrimental to blastocyst development (Quinn P, Moinipanah R, Steinberg J, Weathersbee P: Fertil Steril 1995;63:922-924). IVC-THREE Blastocyst Medium may be used as a stand alone medium or as the second stage of a sequential medium protocol.
INVITROCARE, INCORPORATED
2007-V
In Commercial Distribution

  • 00859268006107 ()
2007-V

  • IVF medium
IVC-TWO is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.The formulation of IVC-TWO is substantially equivalent to the glucose and phosphate free HTF formulation published by Quinn et al (Quinn P, Moinipanah R, Steinberg J, Weathersbee P: Fertil Steril 1995;63:922-924). IVC-TWO is designed to support early stages of embryonic growth (up to four days post-fertilization). IVC-TWO has been formulated without phosphate, which may be detrimental to embryo blastocyst development. IVC-TWO may be used as a stand alone medium or as the first stage of a sequential medium protocol.
INVITROCARE, INCORPORATED
2008-V
In Commercial Distribution

  • 00859268006091 ()
2008-V

  • IVF medium
PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3 MFSS suture with 2 curved needles (white wrap) 1x size #3 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar for #3 SS sutures Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
600-4001
In Commercial Distribution

  • 00859210006070 ()

  • Size #3 Suture
600-4001

  • Metallic suture, multifilament
PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains: 1x Pre-drill, size 0.063" diameter x 4" length 1x Pre-drill, size 0.078" diameter x 4" length 1x Pre-drill, size 0.094" diameter x 4" length > For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565) Supplied Non-Sterile.
PONTIS ORTHOPAEDICS, LLC
400-3015
In Commercial Distribution

  • 00859210006049 ()

  • Length: 4 Inch
  • Outer Diameter: 0.094 Inch
  • Outer Diameter: 0.078 Inch
  • Outer Diameter: 0.063 Inch
400-3015

  • Orthopaedic trocar blade, reusable
PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3-0 MFSS suture with 2 curved needles (white wrap) 1x size #3-0 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
400-3011
In Commercial Distribution

  • 00859210006001 ()

  • 3-0 suture size
400-3011

  • Metallic suture, multifilament
No Description
SCANMED, LLC
516PH3001
In Commercial Distribution

  • 00859193006463 ()


  • MRI system coil, radio-frequency
No Description
SCANMED, LLC
516SI3001
In Commercial Distribution

  • 00859193006180 ()


  • MRI system coil, radio-frequency
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