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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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Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-ITH-01
In Commercial Distribution

  • 04719878713733 ()


  • Surgical planning/navigation-enhancement system
PULSE Single Patient Reference Array Kit
Nuvasive, Inc.
5050401
In Commercial Distribution

  • 00195377051004 ()


  • Spinal rod bending system
Fixed Screwdriver, Navigation
ALPHATEC SPINE, INC.
17060-N
In Commercial Distribution

  • 00190376394428 ()


  • Spinal rod bending system
Sagittal Bender, Double Ended Right
Kalitec Direct LLC
15-K04-3021
In Commercial Distribution

  • B07315K0430210 ()
15-K04-3021

  • Spinal rod bending system
Sagittal Bender, Double Ended Left
Kalitec Direct LLC
15-K04-3020
In Commercial Distribution

  • B07315K0430200 ()
15-K04-3020

  • Spinal rod bending system
T-Handle, Head Persuader
Kalitec Direct LLC
15-K01-2210
In Commercial Distribution

  • B07315K0122100 ()
15-K01-2210

  • Spinal rod bending system
Rod Bender, 5.5 mm, 5 Position
Kalitec Direct LLC
11-K07-3006
In Commercial Distribution

  • B07311K0730060 ()


  • Spinal rod bending system
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
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