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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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Prime NM Implant, 39x27mm x 16mm, 10 Deg
Seaspine Orthopedics Corporation
35-97-1610
In Commercial Distribution

  • 10889981139360 ()

  • 39x27mm x 16mm, 10 Deg
35-97-1610

  • Spinal implant trial
Prime NM Implant, 39x27mm x 14mm, 10 Deg
Seaspine Orthopedics Corporation
35-97-1410
In Commercial Distribution

  • 10889981139353 ()

  • 39x27mm x 14mm, 10 Deg
35-97-1410

  • Spinal implant trial
Prime NM Implant, 39x27mm x 12mm, 10 Deg
Seaspine Orthopedics Corporation
35-97-1210
In Commercial Distribution

  • 10889981139346 ()

  • 39x27mm x 12mm, 10 Deg
35-97-1210

  • Spinal implant trial
Prime NM Implant, 39x27mm x 10mm, 10 Deg
Seaspine Orthopedics Corporation
35-97-1010
In Commercial Distribution

  • 10889981139339 ()

  • 39x27mm x 10mm, 10 Deg
35-97-1010

  • Spinal implant trial
Starter Trial 6mm
Seaspine Orthopedics Corporation
98-3106
In Commercial Distribution

  • 10889981139087 ()

  • 6mm
98-3106

  • Spinal implant trial
Trial 12mm
Seaspine Orthopedics Corporation
98-3112
In Commercial Distribution

  • 10889981138929 ()

  • 12mm
98-3112

  • Spinal implant trial
Trial 10mm
Seaspine Orthopedics Corporation
98-3110
In Commercial Distribution

  • 10889981138912 ()

  • 10mm
98-3110

  • Spinal implant trial
Trial 8mm
Seaspine Orthopedics Corporation
98-3108
In Commercial Distribution

  • 10889981138905 ()

  • 8mm
98-3108

  • Spinal implant trial
4.0mm Variable Screw, Self Tapping, 20mm
Seaspine Orthopedics Corporation
85-4020
In Commercial Distribution

  • 10889981137458 ()

  • 4.0mm, 20mm
85-4020

  • Spinal implant trial
3.5mm Variable Screw, Self-Drilling, 20mm
Seaspine Orthopedics Corporation
85-3220
In Commercial Distribution

  • 10889981137434 ()

  • 3.5mm, 20mm
85-3220

  • Spinal implant trial
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