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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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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
IN-SITU BENDERS, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1400
In Commercial Distribution

  • B06210101400 ()
1010-1400

  • Spinal rod bending system
ROD BENDER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1017
In Commercial Distribution

  • B06210101017 ()
1010-1017

  • Spinal rod bending system
TUBE ROD BENDER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1550
In Commercial Distribution

  • B06210101550 ()
1010-1550

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

  • 00190376394428 ()


  • Spinal rod bending system
Bendini ASF Pointer
Nuvasive, Inc.
8210314
In Commercial Distribution

  • 00887517605078 ()


  • Spinal rod bending system
Bendini Adjustable Open Pointer
Nuvasive, Inc.
8210312
In Commercial Distribution

  • 00887517605054 ()


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

  • 00887517590268 ()


  • Spinal rod bending system
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