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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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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
Screwdriver, Extended Tab, Fixed Tap Sleeve, Assembly
Kalitec Direct LLC
11-K01-2023
In Commercial Distribution

  • B07311K0120230 ()


  • 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, Extended Tab, Cannulated, Lockable
Kalitec Direct LLC
11-K01-2021
In Commercial Distribution

  • B07311K0120210 ()
11-K01-2021

  • 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
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