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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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NIDO Pedicle Screw System - B07315K0140200

T-Handle, T30 Split Tip Cap Starter
Kalitec Direct LLC
15-K01-4020
In Commercial Distribution

  • B07315K0140200 ()
15-K01-4020

  • Surgical screwdriver, reusable

NIDO Pedicle Screw System - B07315K0120200

Screwdriver, Modular Bone Screws
Kalitec Direct LLC
15-K01-2020
In Commercial Distribution

  • B07315K0120200 ()
15-K01-2020

  • Surgical screwdriver, reusable

NIDO Pedicle Screw System - B07315K0120100

Assembly, Screwdriver, NIDO Assembled Screws
Kalitec Direct LLC
15-K01-2010
In Commercial Distribution

  • B07315K0120100 ()
15-K01-2010

  • Surgical screwdriver, reusable

Navagio - B073DRK0100330

Assembly, Navagio Fixed Draw Rod, Large Knob
Kalitec Direct LLC
DR-K01-0033
In Commercial Distribution

  • B073DRK0100330 ()
DR-K01-0033

  • Orthopaedic implant driver

Kalitec Special - B073DRK0100200

SNII Screwdriver, Poly Std Assembly
Kalitec Direct LLC
DR-K01-0020
In Commercial Distribution

  • B073DRK0100200 ()
DR-K01-0020

  • Surgical screwdriver, reusable

InSePtion MIS Fixation System - B07314K0120500

Inserter, All-In-One
Kalitec Direct LLC
14-K01-2050
In Commercial Distribution

  • B07314K0120500 ()


  • Orthopaedic implant driver

InSePtion MIS Fixation System - B07314K0120100

Inserter, Core
Kalitec Direct LLC
14-K01-2010
In Commercial Distribution

  • B07314K0120100 ()


  • Orthopaedic implant driver

CosmoLock Pedicle Screw System - B07311K0140030

Cap Starter, T30, Split Tip, Quarter Square
Kalitec Direct LLC
11-K01-4003
In Commercial Distribution

  • B07311K0140030 ()


  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0140020

Driver Shaft, T30 No Taper, Final Cap Driver
Kalitec Direct LLC
11-K01-4002
In Commercial Distribution

  • B07311K0140020 ()


  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0140010

T-Handle, T30 Split Tip Cap Starter
Kalitec Direct LLC
11-K01-4001
In Commercial Distribution

  • B07311K0140010 ()


  • Surgical screwdriver, reusable
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