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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, T-Handle, T15 Split Tip Cross Connector
Kalitec Direct LLC
10-K01-4200
In Commercial Distribution

  • B07310K0142000 ()


  • Surgical screwdriver, reusable
T-Handle, T30 Split Tip Cap Starter, MIS
Kalitec Direct LLC
10-K01-4020
In Commercial Distribution

  • B07310K0140200 ()


  • Surgical screwdriver, reusable
Driver Shaft, T30 Final Cap, MIS
Kalitec Direct LLC
10-K01-4002
In Commercial Distribution

  • B07310K0140020 ()


  • Surgical screwdriver, reusable
Screwdriver, Tower Tab, Cannulated
Kalitec Direct LLC
10-K01-2001
In Commercial Distribution

  • B07310K0120010 ()


  • Surgical screwdriver, reusable
Inserter Draw Rod, InTess C
Kalitec Direct LLC
09-K01-0004
In Commercial Distribution

  • B07309K0100040 ()


  • Orthopaedic implant driver
Implant Inserter, InTess C
Kalitec Direct LLC
09-K01-0003
In Commercial Distribution

  • B07309K0100030 ()


  • Orthopaedic implant driver
Driver Shaft, Final Tighten
Kalitec Direct LLC
08-K01-2002
In Commercial Distribution

  • B07308K0120020 ()


  • Surgical screwdriver, reusable
Draw Rod, Universal Assembly
Kalitec Direct LLC
08-K01-2001
In Commercial Distribution

  • B07308K0120010 ()


  • Orthopaedic implant driver
Screw Driver, Cannulated Assembly
Kalitec Direct LLC
08-K01-2000
In Commercial Distribution

  • B07308K0120000 ()


  • Surgical screwdriver, reusable
Assembly, Driver Shaft, T-Handle, Locking Cam
Kalitec Direct LLC
07-K01-7320
In Commercial Distribution

  • B07307K0173200 ()
07-K01-7320

  • Surgical screwdriver, reusable
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