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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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VERTECEM II - 10705034721699

VERTECEM V+ SYRINGE KIT
Synthes GmbH
03.702.215S
In Commercial Distribution

  • H98103702215S0 ()
  • 10705034721699 ()
  • 07611819396074 ()
03702215S

  • Orthopaedic cement preparation/delivery kit

VORTEX - 03596010457080

VORTEX AND MIXOR NOZZLE LONG TAPERED
Smith & Nephew, Inc.
71270081
In Commercial Distribution

  • 23596010457084 ()
  • 03596010457080 ()
71270081

  • Orthopaedic cement preparation/delivery kit

VORTEX - 03596010456434

VORTEX AND MIXOR NOZZLE UMBRELLA
Smith & Nephew, Inc.
71270085
In Commercial Distribution

  • 23596010456438 ()
  • 03596010456434 ()
71270085

  • Orthopaedic cement preparation/delivery kit

VORTEX - 03596010456427

VORTEX RE-USE KIT
Smith & Nephew, Inc.
71270071
In Commercial Distribution

  • 03596010456427 ()
71270071

  • Orthopaedic cement preparation/delivery kit

JET-VAC - 03596010454515

RICHARDS JET-VAC HIP KIT
Smith & Nephew, Inc.
890110
Not in Commercial Distribution

  • 03596010454515 ()
890110

  • Orthopaedic cement preparation/delivery kit

VORTEX - 03596010464873

MIXOR AND VORTEX NOZZLE ANGLED
Smith & Nephew, Inc.
71270082
In Commercial Distribution

  • 23596010464877 ()
  • 03596010464873 ()
71270082

  • Orthopaedic cement preparation/delivery kit

Mendec V FILL - 08031497001456

The device is an accessory intended to fill up to six needles or fillers with acrylic resins for vertebroplasty/kyphoplasty at the same time.
TECRES SPA
ASC0000
In Commercial Distribution

  • 08031497001456 ()


  • Orthopaedic cement preparation/delivery kit

HP Connection Tube - 08031497002255

HP Connection Tube is intended for the connection of delivery devices to injection devices through Luer-Lock connections for the extrusion of bone void fillers or acrylic resins.
TECRES SPA
ASB0250
In Commercial Distribution

  • 08031497002255 ()


  • Orthopaedic cement preparation/delivery kit

BIOPSYBELL - 08033860036584

Device for cement infusion in the vertebroplasty procedures
BIOPSYBELL SRL
EASYNJECT
In Commercial Distribution

  • 08033860036591 ()
  • 08033860036584 ()
KVTGUN-DS1

  • Orthopaedic cement preparation/delivery kit

BIOPSYBELL - 08033860034733

KYPHOPLASTY DRILL
BIOPSYBELL SRL
CIFOPACK DRILL
In Commercial Distribution

  • 08033860034733 ()

  • Needle Gauge: 11 Gauge
  • Outer Diameter: 3.00 Millimeter
KPA11-DRI

  • Orthopaedic cement preparation/delivery kit
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