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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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Songer® Spinal Cable System - 00840298704392

(2) Bar, Flat
Pioneer Surgical Technology, Inc.
400-108
In Commercial Distribution

7825-017

  • Internal spinal fixation system cable

Songer® Spinal Cable System - 00840298704385

(1) Ø1.25mm Single Loop Cable with Crimp, (1) Crimp, Flange, (1) Bar, Round
Pioneer Surgical Technology, Inc.
400-203
In Commercial Distribution

7925-013S

  • Internal spinal fixation system cable

Songer® Spinal Cable System - 00840298704378

(1) Ø1.25mm Small Cable, Double Loop with Crimps (Flexible Bar)
Pioneer Surgical Technology, Inc.
400-216
In Commercial Distribution

7925-018S

  • Internal spinal fixation system cable

Songer® Spinal Cable System - 00840298704361

(1) Ø1.25mm Large Cable, Double Loop with Crimps (Flexible Bar)
Pioneer Surgical Technology, Inc.
400-217
In Commercial Distribution

7925-019S

  • Internal spinal fixation system cable

Songer® Spinal Cable System - 00840298704354

(1) Ø1.25mm Large Cable, Double Loop with Crimps (Flexible Bar)
Pioneer Surgical Technology, Inc.
400-219
In Commercial Distribution

7925-019

  • Internal spinal fixation system cable

Songer® Spinal Cable System - 00840298704347

(1) Ø1.25mm Small Cable, Double Loop with Crimps (Flexible Bar)
Pioneer Surgical Technology, Inc.
400-218
In Commercial Distribution

7925-018

  • Internal spinal fixation system cable

Axonics - 10810005340158

Tined Lead
AXONICS MODULATION TECHNOLOGIES, INC.
2201
In Commercial Distribution

  • 10810005340158 ()
2201

  • Sacral plexus implantable incontinence-control electrical stimulation system electrode

Axonics - 10810005340141

Tined Lead Kit
AXONICS MODULATION TECHNOLOGIES, INC.
1201
In Commercial Distribution

  • 10810005340141 ()
1201

  • Sacral plexus implantable incontinence-control electrical stimulation system electrode

ResCUBE™ - 03760185576109

The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: - A ligament allowing correction and stabilization of the levels, after tensioning - A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. - A low-profile connector holding the tension on the ligament
COUSIN BIOTECH
RCBCUBETUU
In Commercial Distribution

  • 03760185576109 ()


  • Internal spinal fixation system cable

StratPac - 10884521548343

Instrument Kit
Covidien LP
2068SS
Not in Commercial Distribution

  • 10884521548343 ()


  • Meniscus screw
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