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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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DFINE® - 00884450296172

No Description
Merit Medical Systems, Inc.
00884450296172
In Commercial Distribution

  • 10884450296179 ()
  • 00884450296172 ()
1402/A

  • Orthopaedic cement preparation/delivery kit

DFINE® - 00884450374399

No Description
Merit Medical Systems, Inc.
00884450374399
In Commercial Distribution

  • 00884450374399 ()
1402/B

  • Orthopaedic cement preparation/delivery kit

DFINE® - 00884450374375

No Description
Merit Medical Systems, Inc.
00884450374375
In Commercial Distribution

  • 00884450374375 ()
3427/B

  • Orthopaedic cement preparation/delivery kit

StabiliT TOUCH™ Syringe - 00884450357019

No Description
Merit Medical Systems, Inc.
00884450357019
In Commercial Distribution

  • 00884450357019 ()
IN8VCF/A

  • Orthopaedic cement preparation/delivery kit

StabiliT TOUCH™ Syringe - 00884450837542

No Description
Merit Medical Systems, Inc.
C
In Commercial Distribution

  • 10884450837549 ()
  • 00884450837542 ()
IN8VCF

  • Orthopaedic cement preparation/delivery kit

StabiliT TOUCH™ Syringe - 00884450662144

No Description
Merit Medical Systems, Inc.
00884450662144
In Commercial Distribution

  • 10884450662141 ()
  • 00884450662144 ()
IN8VCF/B

  • Orthopaedic cement preparation/delivery kit

MENDEC AQUA CARTRIDGE - 28031497002006

Mendec Aqua Cartridge is intended to be used with Mendec Aqua in vertebral augmentation procedure (vertebroplasty, kyphoplasty and screw-augmentation) when the acrylic resin/bone void filler loaded in a single cartridge is not sufficient to complete the surgical procedure.
TECRES SPA
ASC0030
In Commercial Distribution

  • 28031497002006 ()


  • Orthopaedic cement preparation/delivery kit

MENDEC AQUA - 28031497001702

MENDEC AQUA is a sterile single-use device for extrusion into the bone of acrylic resins or bone void fillers (not supplied with the kit) intended for vertebral augmentation procedures (vertebroplasty, kyphoplasty, screw-augmentation).
TECRES SPA
ASC0020
In Commercial Distribution

  • 28031497001702 ()


  • Orthopaedic cement preparation/delivery kit

XTRUDER - 28031497001436

XTRUDER is intended for extrusion of acrylic resins or bone void fillers prepared with Tecres SHAKIT.
TECRES SPA
ASA0390
In Commercial Distribution

  • 28031497001436 ()


  • Orthopaedic cement preparation/delivery kit

Shakit - 28031497001429

Shakit is intended for mixing acrylic resins or bone void fillers components.
TECRES SPA
ASA0380
In Commercial Distribution

  • 28031497001429 ()


  • Orthopaedic cement preparation/delivery kit
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