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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KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP
BIOPSYBELL SRL
KYPHOKIT WORKING CANNULA AND DIAMOND TIP
In Commercial Distribution

  • 08033860041694 ()

  • Needle Gauge: 11 Gauge
  • Length: 120 Millimeter
KK11-WD

  • Bone access channel kit
KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP
BIOPSYBELL SRL
CIFOPACK WORKING CANNULA AND DIAMOND TIP
In Commercial Distribution

  • 08033860041687 ()

  • Needle Gauge: 08 Gauge
KPA08-WD

  • Bone access channel kit
Automatic guillotine needle for soft tissue biopsy
BIOPSYBELL SRL
ESTER & INTRODUTTORE
In Commercial Distribution

  • 08033860041533 ()

  • Needle Gauge: 20 Gauge
  • Length: 200 Millimeter
GUNTR2020EC

  • End-cut biopsy gun handpiece/needle
KYPHOPLASTY WORKING CANNULA AND TROCAR TIP
BIOPSYBELL SRL
CIFOPACK WORKING CANNULA AND TROCAR TIP
In Commercial Distribution

  • 08033860040307 ()

  • Needle Gauge: 13 Gauge
  • Length: 120 Millimeter
KPA13-WTR

  • Bone access channel 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 WORKING CANNULA AND BEVEL/TROCAR TIP
BIOPSYBELL SRL
KYPHOKIT WORKING CANNULA AND BEVEL/TROCAR TIP
In Commercial Distribution

  • 08033860038830 ()

  • Needle Gauge: 11 Gauge
  • Length: 120 Millimeter
KK11-WTRB

  • Bone access channel 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
Semiautomatic guillotine needle for soft-tissue biopsy
BIOPSYBELL SRL
SPEEDYBELL DOPPIA CORSA
In Commercial Distribution

  • 08033860038106 ()

  • Needle Gauge: 19 Gauge
  • Length: 100 Millimeter
SBD1910EC

  • End-cut biopsy gun handpiece/needle
Kyphoplasty kirschner guide
BIOPSYBELL SRL
K-WIRE
In Commercial Distribution

  • 08033860037901 ()

  • Guidewire Length: 600 Millimeter
  • Guidewire Diameter: 1.40 Millimeter
03.75.10.0218

  • Bone access channel kit
Semiautomatic guillotine needle for soft-tissue biopsy
BIOPSYBELL SRL
SPEEDYBELL DOPPIA CORSA
In Commercial Distribution

  • 08033860037871 ()

  • Length: 250 Millimeter
  • Needle Gauge: 14 Gauge
SBD1425EC

  • End-cut biopsy gun handpiece/needle
KYPHOPLASTY BALLOON CATHETER
BIOPSYBELL SRL
KYPHOPLASTY BALLOON CATHETER
In Commercial Distribution

  • 08033860037826 ()

  • Needle Gauge: 13 Gauge
RESB1315US

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

  • 08033860037055 ()

  • Needle Gauge: 13 Gauge
  • Length: 150 Millimeter
BAN1315CDT

  • Bone access channel kit
Semiautomatic guillotine needle for soft-tissue biopsy
BIOPSYBELL SRL
SPEEDYBELL
In Commercial Distribution

  • 08033860037017 ()

  • Length: 250 Millimeter
  • Needle Gauge: 14 Gauge
SB1425EC

  • End-cut biopsy gun handpiece/needle
KYPHOPLASTY WORKING CANNULA AND BEVEL TIP
BIOPSYBELL SRL
CIFOPACK WORKING CANNULA AND BEVEL TIP
In Commercial Distribution

  • 08033860036942 ()

  • Needle Gauge: 11 Gauge
  • Length: 120 Millimeter
KPA11-WB

  • Bone access channel kit
KYPHOPLASTY FAST ACCESS BONE ACCESS KIT
BIOPSYBELL SRL
CIFOPACK FAST ACCESS SYSTEM
In Commercial Distribution

  • 08033860036850 ()

  • Needle Gauge: 11 Gauge
KPA11-001V

  • Bone access channel kit
KYPHOPLASTY FAST ACCESS BONE ACCESS KIT
BIOPSYBELL SRL
KYPHOKIT FAST ACCESS SYSTEM
In Commercial Distribution

  • 08033860036713 ()

  • Needle Gauge: 11 Gauge
KK11-001V

  • Bone access channel kit
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT Marrow-Tray
In Commercial Distribution

  • 08033860036690 ()

  • Needle Gauge: 13 Gauge
  • Length: 100 Millimeter
MTR1310C-US

  • Bone marrow explant needle
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT Marrow-Tray
In Commercial Distribution

  • 08033860036683 ()

  • Needle Gauge: 11 Gauge
  • Length: 100 Millimeter
MTR1110C-US

  • Bone marrow explant needle
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT Marrow-Set
In Commercial Distribution

  • 08033860036676 ()

  • Needle Gauge: 13 Gauge
  • Length: 100 Millimeter
MSE1310C-US

  • Bone marrow explant needle
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT Marrow-Set
In Commercial Distribution

  • 08033860036669 ()

  • Needle Gauge: 11 Gauge
  • Length: 100 Millimeter
MSE1110C-US

  • Bone marrow explant needle
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT Marrow-Pack
In Commercial Distribution

  • 08033860036652 ()

  • Needle Gauge: 13 Gauge
  • Length: 100 Millimeter
MPA1310C-US

  • Bone marrow explant needle
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT Marrow-Pack
In Commercial Distribution

  • 08033860036645 ()

  • Needle Gauge: 11 Gauge
  • Length: 100 Millimeter
MPA1110C-US

  • Bone marrow explant needle
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT Marrow-Kit
In Commercial Distribution

  • 08033860036638 ()

  • Needle Gauge: 13 Gauge
  • Length: 100 Millimeter
MAK1310C-US

  • Bone marrow explant needle
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT Marrow-Kit
In Commercial Distribution

  • 08033860036621 ()

  • Needle Gauge: 11 Gauge
  • Length: 100 Millimeter
MAK1110C-US

  • Bone marrow explant needle
Device for cement infusion in the vertebroplasty procedures
BIOPSYBELL SRL
EASYNJECT
In Commercial Distribution

  • 08033860036591 ()
  • 08033860036584 ()
KVTGUN-DS1

  • Orthopaedic cement preparation/delivery kit
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT Marrow-Stem
In Commercial Distribution

  • 08033860036324 ()

  • Needle Gauge: 13 Gauge
  • Length: 100 Millimeter
MWS1310C-US

  • Bone marrow explant needle
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
BIOPSYBELL SRL
BONE MARROW MSC ASPIRATION KIT-MARROW-STEM
In Commercial Distribution

  • 08033860036317 ()

  • Length: 10 Centimeter
  • Needle Gauge: 11 Gauge
MWS1110C-US

  • Bone marrow explant needle
BONE ACCESS NEEDLE
BIOPSYBELL SRL
BONE ACCESS NEEDLE
In Commercial Distribution

  • 08033860036430 ()
  • 08033860036300 ()

  • Needle Gauge: 8 Gauge
  • Length: 120 Millimeter
BAN0812CDT

  • Bone access channel kit
BONE ACCESS NEEDLE
BIOPSYBELL SRL
BONE ACCESS NEEDLE
In Commercial Distribution

  • 08033860036256 ()

  • Needle Gauge: 08 Gauge
  • Length: 150 Millimeter
BAN0815CDT

  • Bone access channel kit
KYPHOPLASTY CLASSIC ACCESS BONE KIT
BIOPSYBELL SRL
CIFOPACK CLASSIC ACCESS SYSTEM
In Commercial Distribution

  • 08033860035907 ()

  • Needle Gauge: 08 Gauge
KPA08-001L

  • Bone access channel kit
KYPHOPLASTY KIRSCHNER GUIDE
BIOPSYBELL SRL
CIFOPACK KIRSCHNER GUIDE
In Commercial Distribution

  • 08033860035877 ()

  • Needle Gauge: 11 Gauge
KPA11FGP

  • Bone access channel kit
KYPHOPLASTY BONE ACCESS NEEDLE
BIOPSYBELL SRL
CIFOPACK BONE ACCESS NEEDLE
In Commercial Distribution

  • 08033860035860 ()

  • Needle Gauge: 11 Gauge
KPA11-OB

  • Bone access channel kit
KYPHOPLASTY CLASSIC ACCESS BONE KIT
BIOPSYBELL SRL
KYPHOKIT CLASSIC ACCESS SYSTEM
In Commercial Distribution

  • 08033860035181 ()

  • Needle Gauge: 08 Gauge
KK08-001L

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

  • 08033860035150 ()

  • Length: 100 Millimeter
  • Needle Gauge: 20 Gauge
GUN2010EC-OS

  • End-cut biopsy gun handpiece/needle
KYPHOPLASTY BONE FILLER KIT
BIOPSYBELL SRL
RENOVA SPINE BONE FILLER
In Commercial Distribution

  • 08033860034818 ()

  • Needle Gauge: 10 Gauge
  • Length: 187 Millimeter
RESFIL1112C1-US

  • Vertebral body cement cannula
KYPHOPLASTY DRILL
BIOPSYBELL SRL
RENOVA SPINE KYPHOPLASTY DRILL
In Commercial Distribution

  • 08033860034771 ()

  • Length: 187 Millimeter
  • Needle Gauge: 10 Gauge
RESDRI1112C-US

  • Bone access channel kit
KYPHOPLASTY WORKING CANNULA AND TROCAR TIP
BIOPSYBELL SRL
RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP
In Commercial Distribution

  • 08033860034764 ()

  • Needle Gauge: 10 Gauge
  • Length: 120 Millimeter
RESWTR1112C-US

  • Bone access channel kit
KYPHOPLASTY WORKING CANNULA AND BEVEL TIP
BIOPSYBELL SRL
RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP
In Commercial Distribution

  • 08033860034757 ()

  • Needle Gauge: 10 Gauge
  • Length: 120 Millimeter
RESWB1112C-US

  • Bone access channel kit
KYPHOPLASTY BONE FILLER KIT
BIOPSYBELL SRL
CIFOPACK BONE FILLER
In Commercial Distribution

  • 08033860034740 ()

  • Needle Gauge: 11 Gauge
KPA11-FIL

  • Vertebral body cement cannula
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
Semiautomatic guillotine needle for soft-tissue biopsy
BIOPSYBELL SRL
SPEEDYBELL DOPPIA CORSA
In Commercial Distribution

  • 08033860032364 ()

  • Needle Gauge: 16 Gauge
  • Length: 250 Millimeter
SBD1625EC

  • End-cut biopsy gun handpiece/needle
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
Kyphoplasty kirschner guide
BIOPSYBELL SRL
K-WIRE
In Commercial Distribution

  • 08033860030353 ()

  • Guidewire Length: 600 Millimeter
  • Guidewire Diameter: 1.40 Millimeter
03.75.10.0219

  • Bone access channel 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
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
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