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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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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
KYPHOPLASTY BALLOON CATHETER
BIOPSYBELL SRL
KYPHOPLASTY BALLOON CATHETER
In Commercial Distribution

  • 08033860030193 ()

  • Needle Gauge: 10 Gauge
RESB1020US

  • Inflatable bone tamp
KYPHOPLASTY BALLOON CATHETER
BIOPSYBELL SRL
KYPHOPLASTY BALLOON CATHETER
In Commercial Distribution

  • 08033860030186 ()

  • Needle Gauge: 10 Gauge
RESB1015US

  • Inflatable bone tamp
KYPHOPLASTY BALLOON CATHETER
BIOPSYBELL SRL
KYPHOPLASTY BALLOON CATHETER
In Commercial Distribution

  • 08033860030179 ()

  • Needle Gauge: 10 Gauge
RESB1010US

  • Inflatable bone tamp
BONE ACCESS NEEDLE
BIOPSYBELL SRL
BONE ACCESS NEEDLE
In Commercial Distribution

  • 08033860029166 ()

  • Needle Gauge: 13 Gauge
  • Length: 120 Millimeter
BAN1312CDT

  • Bone access channel kit
KYPHOPLASTY TOOL KIT
BIOPSYBELL SRL
RENOVA SPINE KYPHOPLASTY TOOL KIT
In Commercial Distribution

  • 08033860028787 ()

  • Needle Gauge: 10 Gauge
RESFAST11-001

  • Balloon kyphoplasty kit
Kyphoplasty kirschner guide
BIOPSYBELL SRL
K-WIRE
In Commercial Distribution

  • 08033860028602 ()

  • Guidewire Length: 600 Millimeter
  • Guidewire Diameter: 1.40 Millimeter
03.75.10.0217

  • Bone access channel kit
Kyphoplasty kirschner guide
BIOPSYBELL SRL
K-WIRE
In Commercial Distribution

  • 08033860028596 ()

  • Guidewire Diameter: 1.40 Millimeter
  • Guidewire Length: 600 Millimeter
03.75.10.0216

  • Bone access channel kit
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860028459 ()

  • Length: 150 Millimeter
  • Needle Gauge: 20 Gauge
GUN2015EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860028442 ()

  • Length: 200 Millimeter
  • Needle Gauge: 20 Gauge
GUN2020EC-OS

  • End-cut biopsy gun handpiece/needle
Semiautomatic guillotine needle for soft-tissue biopsy
BIOPSYBELL SRL
SPEEDYBELL DOPPIA CORSA & INTRODUTTORE
In Commercial Distribution

  • 08033860028220 ()

  • Length: 100 Millimeter
  • Needle Gauge: 19 Gauge
SBDTR1910EC

  • End-cut biopsy gun handpiece/needle
VERTEBROPLASTY/KYPHOPLASTY MIXING CEMENT SYSTEM
BIOPSYBELL SRL
CEMENT MIXING SYSTEM
In Commercial Distribution

  • 08033860028022 ()
  • 08033860028039 ()
VCF-1051

  • Orthopaedic cement mixing bowl
NEEDLE FOR BONE-MARROW BIOPSY
BIOPSYBELL SRL
ILIAC MARROW
In Commercial Distribution

  • 08033860027810 ()

  • Length: 100 Millimeter
  • Needle Gauge: 18 Gauge
IM1810

  • Bone marrow biopsy procedure kit
Bone marrow biopsy or explantation needle with anti-luxation system
BIOPSYBELL SRL
UNLUX SYSTEM
In Commercial Distribution

  • 08033860027179 ()

  • Needle Gauge: 13 Gauge
  • Length: 60 Millimeter
ULSEC1306C

  • Bone marrow biopsy procedure kit
Semiautomatic guillotine needle for soft-tissue biopsy
BIOPSYBELL SRL
SPEEDYBELL & INTRODUTTORE
In Commercial Distribution

  • 08033860026882 ()

  • Length: 200 Millimeter
  • Needle Gauge: 14 Gauge
SBTR1420EC

  • End-cut biopsy gun handpiece/needle
Semiautomatic guillotine needle for soft-tissue biopsy
BIOPSYBELL SRL
SPEEDYBELL DOPPIA CORSA & INTRODUTTORE
In Commercial Distribution

  • 08033860026745 ()

  • Length: 200 Millimeter
  • Needle Gauge: 21 Gauge
SBDTR2120EC

  • End-cut biopsy gun handpiece/needle
Semiautomatic guillotine needle for soft-tissue biopsy
BIOPSYBELL SRL
SPEEDYBELL DOPPIA CORSA & INTRODUTTORE
In Commercial Distribution

  • 08033860026707 ()

  • Length: 100 Millimeter
  • Needle Gauge: 15 Gauge
SBDTR1510EC

  • End-cut biopsy gun handpiece/needle
Device for cement infusion in the vertebroplasty procedures
BIOPSYBELL SRL
EASYNJECT "S"
In Commercial Distribution

  • 08033860026592 ()
KVTSI10

  • Orthopaedic cement preparation/delivery kit
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860026431 ()

  • Length: 200 Millimeter
  • Needle Gauge: 16 Gauge
GUN1620EC-OS

  • End-cut biopsy gun handpiece/needle
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