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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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InSePtion MIS Fixation System - B07314K0600110

Tray Insert, ISP, Implant
Kalitec Direct LLC
14-K06-0011
In Commercial Distribution

  • B07314K0600110 ()


  • Surgical instrument/implant rack

Inseption - B07314K0100310

Assembly, Caddie, ISP Implants, Hinged
Kalitec Direct LLC
14-K01-0031
In Commercial Distribution

  • B07314K0100310 ()
14-K01-0031

  • Surgical instrument/implant rack

InSePtion MIS Fixation System - B07314K0100210

Caddie Lid, Implant
Kalitec Direct LLC
14-K01-0021
In Commercial Distribution

  • B07314K0100210 ()


  • Surgical instrument/implant rack

InSePtion MIS Fixation System - B07314K0100200

Caddie, Implant
Kalitec Direct LLC
14-K01-0020
In Commercial Distribution

  • B07314K0100200 ()


  • Surgical instrument/implant rack

InTess Lumbar Cage - B07312K0104020

Caddie, Large, 30mm
Kalitec Direct LLC
12-K01-0402
In Commercial Distribution

  • B07312K0104020 ()


  • Surgical instrument/implant rack

InTess Lumbar Cage - B07312K0104010

Caddie Lid, Cages, Universal
Kalitec Direct LLC
12-K01-0401
In Commercial Distribution

  • B07312K0104010 ()


  • Surgical instrument/implant rack

InTess Lumbar Cage - B07312K0104000

Caddie, Cages, Universal
Kalitec Direct LLC
12-K01-0400
In Commercial Distribution

  • B07312K0104000 ()


  • Surgical instrument/implant rack

Intess L - B07312K0100320

Assembly, Caddie, 30mm Lumbar Implants, Hinged
Kalitec Direct LLC
12-K01-0032
In Commercial Distribution

  • B07312K0100320 ()
12-K01-0032

  • Surgical instrument/implant rack

Intess L - B07312K0100310

Assembly,Caddie, Lumbar Implants, Hinged
Kalitec Direct LLC
12-K01-0031
In Commercial Distribution

  • B07312K0100310 ()
12-K01-0031

  • Surgical instrument/implant rack

Intess L - B07312K0100300

Caddie Lid, Lumbar Implants,Hinged
Kalitec Direct LLC
12-K01-0030
In Commercial Distribution

  • B07312K0100300 ()
12-K01-0030

  • Surgical instrument/implant rack
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