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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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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
Assembly, Screwdriver, Extended Tab
Kalitec Direct LLC
11-K01-2022
In Commercial Distribution

  • B07311K0120220 ()
11-K01-2022

  • Surgical screwdriver, reusable
Assembly, Screwdriver, Polyaxial, Lockable
Kalitec Direct LLC
11-K01-2015
In Commercial Distribution

  • B07311K0120150 ()
11-K01-2015

  • Surgical screwdriver, reusable
Screwdriver, Polyaxial, Standard, Cannulated, Lockable, SNI 1 Assembly
Kalitec Direct LLC
11-K01-2014
In Commercial Distribution

  • B07311K0120140 ()


  • Surgical screwdriver, reusable
Screwdriver, Polyaxial, Standard, Fixed Tap Sleeve Assembly
Kalitec Direct LLC
11-K01-2013
In Commercial Distribution

  • B07311K0120130 ()


  • Surgical screwdriver, reusable
Screwdriver, Polyaxial, Standard
Kalitec Direct LLC
11-K01-2012
In Commercial Distribution

  • B07311K0120120 ()


  • Surgical screwdriver, reusable
Assembly, Screwdriver, Polyaxial, Cannulated, Lockable
Kalitec Direct LLC
11-K01-2011
In Commercial Distribution

  • B07311K0120110 ()
11-K01-2011

  • Surgical screwdriver, reusable
T-Handle, T25, Screw Height Adjuster
Kalitec Direct LLC
11-K01-2002
In Commercial Distribution

  • B07311K0120020 ()


  • Surgical screwdriver, reusable
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