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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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Fenestrated Screw Percutaneous Cannula
BIOPSYBELL SRL
SCREWFIX
In Commercial Distribution

  • 08033860030445 ()

  • Needle Gauge: 16 Gauge
  • Length: 210 Millimeter
03.51.10.0430

  • Orthopaedic cement preparation/delivery kit
SUBCHONDRAL BONE PLASTY
BIOPSYBELL SRL
ORTHOPLASTY
In Commercial Distribution

  • 08033860030278 ()

  • Needle Gauge: 11 Gauge
  • Length: 100 Millimeter
SUB1110C

  • Orthopaedic cement preparation/delivery kit
Fenestrated Screw Percutaneous Cannula
BIOPSYBELL SRL
SCREWFIX
In Commercial Distribution

  • 08033860030254 ()

  • Needle Gauge: 16 Gauge
  • Length: 35 Millimeter
03.51.10.0172

  • Orthopaedic cement preparation/delivery kit
Device for cement infusion in the vertebroplasty procedures
BIOPSYBELL SRL
EASYNJECT "S"
In Commercial Distribution

  • 08033860026592 ()
KVTSI10

  • Orthopaedic cement preparation/delivery kit
Kyphoplasty/Vertebroplasty system
BIOPSYBELL SRL
VERTEBROSTEEL
In Commercial Distribution

  • 08033860015435 ()

  • Needle Gauge: 11 Gauge
KMFVT1112000C-A

  • Orthopaedic cement preparation/delivery kit
Device for cement infusion in the vertebroplasty procedures
BIOPSYBELL SRL
EASYNJECT
In Commercial Distribution

  • 08033860030223 ()
  • 08033860010843 ()
KVTGUN-DS

  • Orthopaedic cement preparation/delivery kit
Device for cement infusion in the vertebroplasty/kyphoplasty procedure
BIOPSYBELL SRL
VERTEBROPLASTY EXTENTION LINES
In Commercial Distribution

  • 08033860039417 ()
PRC-001

  • Orthopaedic cement preparation/delivery kit
KYPHOPLASTY DRILL
BIOPSYBELL SRL
RENOVA SPINE KYPHOPLASTY DRILL
In Commercial Distribution

  • 08033860038724 ()
  • 08033860038717 ()

  • Needle Gauge: 13 Gauge
  • Outer Diameter: 2.30 Millimeter
RESDRI1312C

  • Orthopaedic cement preparation/delivery kit
KYPHOPLASTY DRILL
BIOPSYBELL SRL
KYPHOKIT DRILL
In Commercial Distribution

  • 08033860023065 ()

  • Needle Gauge: 11 Gauge
  • Outer Diameter: 3.00 Millimeter
KK11-DRI

  • Orthopaedic cement preparation/delivery kit
Kyphoplasty/Vertebroplasty system
BIOPSYBELL SRL
VERTEBROPLASTY SYRINGES
In Commercial Distribution

  • 08033860022419 ()
SI02.5L/L-A

  • Orthopaedic cement preparation/delivery kit
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