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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, Fixed, 1/4" Square
Kalitec Direct LLC
12-K03-1017
In Commercial Distribution

  • B07312K0310170 ()
12-K03-1017

  • Surgical torque wrench, reusable
Draw Rod, Primal T- Handle
Kalitec Direct LLC
12-K01-0507
In Commercial Distribution

  • B07312K0105070 ()


  • Orthopaedic implant driver
Inserter Sleeve, All Size Implants
Kalitec Direct LLC
12-K01-0506
In Commercial Distribution

  • B07312K0105060 ()


  • Orthopaedic implant driver
Implant Inserter, 14-16mm, Sleeveless
Kalitec Direct LLC
12-K01-0505
In Commercial Distribution

  • B07312K0105050 ()


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

  • B07312K0105040 ()


  • Orthopaedic implant driver
Implant Inserter, 8-10mm, Sleeveless
Kalitec Direct LLC
12-K01-0503
In Commercial Distribution

  • B07312K0105030 ()


  • 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
Implant Inserter, 8-10mm, Sleeved
Kalitec Direct LLC
12-K01-0500
In Commercial Distribution

  • B07312K0105000 ()


  • Orthopaedic implant driver
Driver Shaft, T15, Cross Link Final Driver
Kalitec Direct LLC
11-K01-5000
In Commercial Distribution

  • B07311K0150000 ()


  • Surgical screwdriver, reusable
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