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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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TSRH® Spinal System - 00721902981159

TSR VAS-TI-10.0X35
MEDTRONIC SOFAMOR DANEK, INC.
X1103135
In Commercial Distribution

  • 00721902981159 ()

  • Outer Diameter: 10.0 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

TSRH® Spinal System - 00721902981128

TSR VAS-TI-11.0X45
MEDTRONIC SOFAMOR DANEK, INC.
X11031145
In Commercial Distribution

  • 00721902981128 ()

  • Outer Diameter: 11.0 Millimeter
  • Length: 45.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD HORIZON® Spinal System - 00721902979507

CDH LEGACY 4.5 CANN MAS 4.5X45
MEDTRONIC SOFAMOR DANEK, INC.
7654545
In Commercial Distribution

  • 00721902979507 ()


  • Spinal bone screw, non-bioabsorbable

N/A - 00721902977985

BUR 1883212HSE SEPTOPLASTY HI SPD 3.2MM
MEDTRONIC XOMED, INC.
1883212HSE
Not in Commercial Distribution

  • 00721902977985 ()

  • Length: 3.2 Millimeter
  • Outer Diameter: 12.0 Millimeter


  • Metal/carbide ENT bur, single-use

TSRH® Spinal System - 00721902977305

7.5 X 45MM SACRAL SCREW
MEDTRONIC SOFAMOR DANEK, INC.
8373745
Not in Commercial Distribution

  • 00721902977305 ()


  • Spinal bone screw, non-bioabsorbable

N/A - 00721902976827

CASE 3280061 ALIF KIT BASE
MEDTRONIC SOFAMOR DANEK, INC.
3280061
In Commercial Distribution

  • 00721902976827 ()


  • Instrument tray, reusable

n/a - 00721902976810

CASE 3280052 GENERAL KIT UPPER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
3280052
In Commercial Distribution

  • 00721902976810 ()


  • Instrument tray, reusable

n/a - 00721902976803

CASE 3280051 GENERAL KIT MIDDLE TRAY
MEDTRONIC SOFAMOR DANEK, INC.
3280051
In Commercial Distribution

  • 00721902976803 ()


  • Instrument tray, reusable

n/a - 00721902976797

CASE 3280050 GENERAL KIT LOWER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
3280050
In Commercial Distribution

  • 00721902976797 ()


  • Instrument tray, reusable

n/a - 00721902976780

CASE 3280048 GENERAL KIT BASE
MEDTRONIC SOFAMOR DANEK, INC.
3280048
In Commercial Distribution

  • 00721902976780 ()


  • Instrument tray, reusable
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