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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Inserter, Locking Plate
Kalitec Direct LLC
14-K01-2020
In Commercial Distribution

  • B07314K0120200 ()


  • Orthopaedic implant driver
Inserter, Core
Kalitec Direct LLC
14-K01-2010
In Commercial Distribution

  • B07314K0120100 ()


  • Orthopaedic implant driver
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
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