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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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Assembly, Screwdriver, NIDO Assembled Screws
Kalitec Direct LLC
15-K01-2010
In Commercial Distribution

  • B07315K0120100 ()
15-K01-2010

  • Surgical screwdriver, reusable
Assembly, Navagio Fixed Draw Rod, Large Knob
Kalitec Direct LLC
DR-K01-0033
In Commercial Distribution

  • B073DRK0100330 ()
DR-K01-0033

  • Orthopaedic implant driver
SNII Screwdriver, Poly Std Assembly
Kalitec Direct LLC
DR-K01-0020
In Commercial Distribution

  • B073DRK0100200 ()
DR-K01-0020

  • Surgical screwdriver, reusable
Inserter, All-In-One
Kalitec Direct LLC
14-K01-2050
In Commercial Distribution

  • B07314K0120500 ()


  • Orthopaedic implant driver
Inserter, Core
Kalitec Direct LLC
14-K01-2010
In Commercial Distribution

  • B07314K0120100 ()


  • Orthopaedic implant driver
Cap Starter, T30, Split Tip, Quarter Square
Kalitec Direct LLC
11-K01-4003
In Commercial Distribution

  • B07311K0140030 ()


  • Surgical screwdriver, reusable
Driver Shaft, T30 No Taper, Final Cap Driver
Kalitec Direct LLC
11-K01-4002
In Commercial Distribution

  • B07311K0140020 ()


  • Surgical screwdriver, reusable
T-Handle, T30 Split Tip Cap Starter
Kalitec Direct LLC
11-K01-4001
In Commercial Distribution

  • B07311K0140010 ()


  • Surgical screwdriver, reusable
Segmental Rod Reducer Driver
Kalitec Direct LLC
11-K01-3012
In Commercial Distribution

  • B07311K0130120 ()
11-K01-3012

  • Orthopaedic rod reducer
Screwdriver, Extended Tab, Cannulated, SNI 1, Lockable, Assembly
Kalitec Direct LLC
11-K01-2024
In Commercial Distribution

  • B07311K0120240 ()


  • Surgical screwdriver, reusable
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