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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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Coronal Bender, Right
Kalitec Direct LLC
11-K03-3016
In Commercial Distribution

  • B07311K0330160 ()


  • Spinal rod bending system
Coronal Bender, Left
Kalitec Direct LLC
11-K03-3015
In Commercial Distribution

  • B07311K0330150 ()


  • Spinal rod bending system
Rod Bender, 5.5 mm, 3 Position
Kalitec Direct LLC
11-K03-3006
In Commercial Distribution

  • B07311K0330060 ()


  • Spinal rod bending system
Bender, Fixed Cross Link, Right
Kalitec Direct LLC
11-K01-5003
In Commercial Distribution

  • B07311K0150030 ()


  • Spinal rod bending system
Bender, Fixed Cross Link, Left
Kalitec Direct LLC
11-K01-5002
In Commercial Distribution

  • B07311K0150020 ()


  • Spinal rod bending system
T-Handle, Head Persuader, 5.5mm
Kalitec Direct LLC
11-K01-3019
In Commercial Distribution

  • B07311K0130190 ()


  • Spinal rod bending system
Sagittal Bender, Right
Kalitec Direct LLC
11-K01-3014
In Commercial Distribution

  • B07311K0130140 ()


  • Spinal rod bending system
Sagittal Bender, Left
Kalitec Direct LLC
11-K01-3013
In Commercial Distribution

  • B07311K0130130 ()


  • Spinal rod bending system
NuVaMap O.R. Calibration Sphere
Nuvasive, Inc.
8210347
In Commercial Distribution

  • 00887517695505 ()


  • Spinal rod bending system
NuVaMap O.R. Imaging Kit
Nuvasive, Inc.
2060040
In Commercial Distribution

  • 00887517590268 ()


  • Spinal rod bending system
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