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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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Inserter, Inline
Kalitec Direct LLC
23-K01-0505
In Commercial Distribution

  • B07323K0105050 ()


  • Orthopaedic implant driver
Inserter, Offset
Kalitec Direct LLC
23-K01-0500
In Commercial Distribution

  • B07323K0105000 ()


  • Orthopaedic implant driver
Draw Rod, Inserter
Kalitec Direct LLC
20-K01-0004
In Commercial Distribution

  • B07320K0100040 ()


  • Orthopaedic implant driver
Screwdriver Assembly, Tower Tab, Cannulated, SNI2
Kalitec Direct LLC
10-K01-7500
In Commercial Distribution

  • B07310K0175000 ()


  • Surgical screwdriver, reusable
Screwdriver Assembly, Tower Tab, SNI1
Kalitec Direct LLC
10-K01-7210
In Commercial Distribution

  • B07310K0172100 ()
10-K01-7210

  • Surgical screwdriver, reusable
Screwdriver Assembly, Tower Tab, Cannulated SNI1
Kalitec Direct LLC
10-K01-7200
In Commercial Distribution

  • B07310K0172000 ()


  • Surgical screwdriver, reusable
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
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