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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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Draw Rod, Primal T- Handle
Kalitec Direct LLC
12-K01-0507
In Commercial Distribution

  • B07312K0105070 ()


  • Orthopaedic implant driver
Implant Inserter, 11-13mm, Sleeveless
Kalitec Direct LLC
12-K01-0504
In Commercial Distribution

  • B07312K0105040 ()


  • Orthopaedic implant driver
Implant Inserter, 14-16mm, Sleeved
Kalitec Direct LLC
12-K01-0502
In Commercial Distribution

  • B07312K0105020 ()


  • Orthopaedic implant driver
Implant Inserter, 11-13mm, Sleeved
Kalitec Direct LLC
12-K01-0501
In Commercial Distribution

  • B07312K0105010 ()


  • Orthopaedic implant driver
T-Handle, T30, Locking Cap Adjuster
Kalitec Direct LLC
11-K01-4007
In Commercial Distribution

  • B07311K0140070 ()


  • Surgical screwdriver, reusable
Driver Shaft, T30 Split Tip Double End Cap Starter
Kalitec Direct LLC
11-K01-4004
In Commercial Distribution

  • B07311K0140040 ()


  • Surgical screwdriver, reusable
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, 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
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