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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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CALIBRA 1ST MOLAR BANDS n.LL 9
LEONE SPA
E1700-09
In Commercial Distribution

  • 08033707017967 ()
E1700-09

  • Orthodontic metal band
CALIBRA 1ST MOLAR BANDS n.LR 9
LEONE SPA
E1605-09
In Commercial Distribution

  • 08033707017608 ()
E1605-09

  • Orthodontic metal band
CALIBRA 1ST MOLAR BANDS n.LR 9
LEONE SPA
E1600-09
In Commercial Distribution

  • 08033707016854 ()
E1600-09

  • Orthodontic metal band
CALIBRA 1ST MOLAR BANDS n.UL 9
LEONE SPA
E1305-09
In Commercial Distribution

  • 08033707010579 ()
E1305-09

  • Orthodontic metal band
CALIBRA 1ST MOLAR BANDS n.UL 9
LEONE SPA
E1300-09
In Commercial Distribution

  • 08033707009825 ()
E1300-09

  • Orthodontic metal band
CALIBRA 1ST MOLAR BANDS n.UR 9
LEONE SPA
E1205-09
In Commercial Distribution

  • 08033707009467 ()
E1205-09

  • Orthodontic metal band
CALIBRA 1ST MOLAR BANDS n.UR 9
LEONE SPA
E1200-09
In Commercial Distribution

  • 08033707008712 ()
E1200-09

  • Orthodontic metal band
WEB 1ST MOLAR BANDS n.LR 9
LEONE SPA
E8605-09
In Commercial Distribution

  • 08033707032564 ()
E8605-09

  • Orthodontic metal band
WEB 1ST MOLAR BANDS n.UL 9
LEONE SPA
E8300-09
In Commercial Distribution

  • 08033707028222 ()
E8300-09

  • Orthodontic metal band
WEB 1ST MOLAR BANDS n.LL 9
LEONE SPA
E8705-09
In Commercial Distribution

  • 08033707033530 ()
E8705-09

  • Orthodontic metal band
WEB 1ST MOLAR BANDS n.LL 9
LEONE SPA
E8700-09
In Commercial Distribution

  • 08033707032885 ()
E8700-09

  • Orthodontic metal band
WEB 1ST MOLAR BANDS n.LR 9
LEONE SPA
E8600-09
In Commercial Distribution

  • 08033707031918 ()
E8600-09

  • Orthodontic metal band
WEB 1ST MOLAR BANDS n.UL 9
LEONE SPA
E8305-09
In Commercial Distribution

  • 08033707028871 ()
E8305-09

  • Orthodontic metal band
Novel-XS Trial, L-5, 9 mm, Tapered
ALPHATEC SPINE, INC.
64797-109-11
In Commercial Distribution

  • 00190376076492 ()

  • Width: 20 Millimeter
  • Length: 18 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial
Novel-XS Trial, L, 9 mm, Tapered
ALPHATEC SPINE, INC.
64797-009-11
In Commercial Distribution

  • 00190376076423 ()

  • Length: 18 Millimeter
  • Width: 20 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial
Novel-XS Trial, M-5, 9 mm, Tapered
ALPHATEC SPINE, INC.
64795-109-11
In Commercial Distribution

  • 00190376076355 ()

  • Height: 9 Millimeter
  • Width: 17 Millimeter
  • Length: 15 Millimeter


  • Spinal implant trial
Novel-XS Trial, M, 9 mm, Tapered
ALPHATEC SPINE, INC.
64795-009-11
In Commercial Distribution

  • 00190376076287 ()

  • Height: 9 Millimeter
  • Width: 17 Millimeter
  • Length: 15 Millimeter


  • Spinal implant trial
Novel-XS Trial, S-5, 9 mm, Tapered
ALPHATEC SPINE, INC.
64793-109-11
In Commercial Distribution

  • 00190376076218 ()

  • Length: 12 Millimeter
  • Width: 14 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial
Novel-XS Trial, S, 9 mm, Tapered
ALPHATEC SPINE, INC.
64793-009-11
In Commercial Distribution

  • 00190376076140 ()

  • Height: 9 Millimeter
  • Width: 14 Millimeter
  • Length: 12 Millimeter


  • Spinal implant trial
25mm T-LIFT Straight Trial, 9 mm
SPINEFRONTIER, INC.
SI02861-02
In Commercial Distribution

  • 00190361037743 ()


  • Polymeric spinal interbody fusion cage
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