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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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ENDOSKELETON® Sterile Barrier System - 00191375011965

Caddy, Medium
TITAN SPINE, LLC
1130-1020
Not in Commercial Distribution

  • 00191375011965 ()

  • Width: 13.5 Inch
  • Medium Caddy for Sterile Interbody Fusion Devices
  • Height: 6.5 Inch
  • Length: 23 Inch
1130-1020

  • Instrument tray, reusable

ENDOSKELETON® Sterile Barrier System - 00191375011958

Caddy, Small
TITAN SPINE, LLC
1130-1030
Not in Commercial Distribution

  • 00191375011958 ()

  • Width: 13.5 Inch
  • Height: 6.5 Inch
  • Length: 15 Inch
  • Small Caddy for Sterile Interbody Fusion Devices
1130-1030

  • Instrument tray, reusable

ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE - 00192896007390

ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH RATCHET, RATCHET ACTIVATING/DEACTIVATING KEY, ROTATION MODULE AND HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-098
In Commercial Distribution


  • FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
2901-098

  • Laparoscopic surgery handle

ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE - 00192896007376

ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH STEPLESS RATCHET, RELEASE KEY, ROTATION MODULE AND HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-092
In Commercial Distribution


  • FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
2901-092

  • Laparoscopic surgery handle

AXIAL RING HANDLE - 00192896007345

AXIAL RING HANDLE WITH RATCHET
SONTEC INSTRUMENTS, INC.
2901-070
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-070

  • Laparoscopic surgery handle

INSULATED METAL HANDLE - 00192896007321

INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD & HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-064
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-064

  • Laparoscopic surgery handle

ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE - 00192896007383

ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH ROTATION MODULE AND HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-096
In Commercial Distribution


  • FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
2901-096

  • Laparoscopic surgery handle

AXIAL HANDLE - 00192896007369

AXIAL HANDLE WITH SPRING & RATCHET
SONTEC INSTRUMENTS, INC.
2901-076
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-076

  • Laparoscopic surgery handle

AXIAL RING HANDLE - 00192896007352

AXIAL RING HANDLE WITHOUT RATCHET
SONTEC INSTRUMENTS, INC.
2901-074
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-074

  • Laparoscopic surgery handle

INSULATED METALHANDLE - 00192896007338

INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD, RATCHET & HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-066
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-066

  • Laparoscopic surgery handle
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