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 BEVEL TIP
BIOPSYBELL SRL
KYPHOKIT WORKING CANNULA AND BEVEL TIP
In Commercial Distribution

  • 08033860023041 ()

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

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

  • 08033860022945 ()

  • Length: 130 Millimeter
  • Needle Gauge: 20 Gauge
SBDTR2013EC

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

  • 08033860022921 ()

  • Length: 130 Millimeter
  • Needle Gauge: 19 Gauge
SBDTR1913EC

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

  • 08033860022471 ()

  • Length: 70 Millimeter
  • Needle Gauge: 21 Gauge
SBDTR2107EC

  • End-cut biopsy gun handpiece/needle
Kyphoplasty/Vertebroplasty system
BIOPSYBELL SRL
VERTEBROPLASTY SYRINGES
In Commercial Distribution

  • 08033860022419 ()
SI02.5L/L-A

  • Orthopaedic cement preparation/delivery kit
KYPHOPLASTY BONE FILLER KIT
BIOPSYBELL SRL
RENOVA SPINE BONE FILLER
In Commercial Distribution

  • 08033860022693 ()
  • 08033860022396 ()

  • Needle Gauge: 08 Gauge
  • Length: 182 Millimeter
RESFIL0812C1

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

  • 08033860022372 ()

  • Length: 130 Millimeter
  • Needle Gauge: 16 Gauge
SBDTR1613EC

  • End-cut biopsy gun handpiece/needle
BONE ACCESS NEEDLE
BIOPSYBELL SRL
BONE ACCESS NEEDLE
In Commercial Distribution

  • 08033860022310 ()

  • Needle Gauge: 11 Gauge
  • Length: 120 Millimeter
BAN1112HCDBPW

  • Bone access channel kit
No Description
BIOPSYBELL SRL
SOMACORE VERIFY S
Not in Commercial Distribution

  • 08033860021863 ()
  • 08033860021856 ()

  • Length: 150 Millimeter
  • Needle Gauge: 18 Gauge
900502-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY S
Not in Commercial Distribution

  • 08033860021849 ()
  • 08033860021832 ()

  • Needle Gauge: 18 Gauge
  • Length: 100 Millimeter
900500-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY S
Not in Commercial Distribution

  • 08033860021825 ()
  • 08033860021818 ()

  • Length: 150 Millimeter
  • Needle Gauge: 16 Gauge
900492-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY S
Not in Commercial Distribution

  • 08033860021801 ()
  • 08033860021795 ()

  • Needle Gauge: 16 Gauge
  • Length: 100 Millimeter
900490-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY S
Not in Commercial Distribution

  • 08033860021788 ()
  • 08033860021771 ()

  • Length: 100 Millimeter
  • Needle Gauge: 14 Gauge
900480-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY
Not in Commercial Distribution

  • 08033860021764 ()
  • 08033860021757 ()

  • Needle Gauge: 20 Gauge
  • Length: 150 Millimeter
900412-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY
Not in Commercial Distribution

  • 08033860021740 ()
  • 08033860021733 ()

  • Length: 100 Millimeter
  • Needle Gauge: 20 Gauge
900410-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY
Not in Commercial Distribution

  • 08033860021726 ()
  • 08033860021719 ()

  • Needle Gauge: 18 Gauge
  • Length: 200 Millimeter
900404-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY
Not in Commercial Distribution

  • 08033860021702 ()
  • 08033860021696 ()

  • Length: 150 Millimeter
  • Needle Gauge: 18 Gauge
900402-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY
Not in Commercial Distribution

  • 08033860021689 ()
  • 08033860021672 ()

  • Length: 100 Millimeter
  • Needle Gauge: 18 Gauge
900400-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY
Not in Commercial Distribution

  • 08033860021665 ()
  • 08033860021658 ()

  • Needle Gauge: 16 Gauge
  • Length: 150 Millimeter
900392-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY
Not in Commercial Distribution

  • 08033860021641 ()
  • 08033860021634 ()

  • Length: 100 Millimeter
  • Needle Gauge: 16 Gauge
900390-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY
Not in Commercial Distribution

  • 08033860021627 ()
  • 08033860021610 ()

  • Needle Gauge: 14 Gauge
  • Length: 150 Millimeter
900382-US

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
BIOPSYBELL SRL
SOMACORE VERIFY
Not in Commercial Distribution

  • 08033860021603 ()
  • 08033860021597 ()

  • Length: 100 Millimeter
  • Needle Gauge: 14 Gauge
900380-US

  • Soft-tissue biopsy procedure kit, non-medicated
NEEDLE FOR BONE-MARROW BIOPSY
BIOPSYBELL SRL
UNLUX SYSTEM
In Commercial Distribution

  • 08033860021078 ()

  • Length: 100 Millimeter
  • Needle Gauge: 11 Gauge
ULS1110R

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

  • 08033860020507 ()

  • Needle Gauge: 16 Gauge
  • Length: 200 Millimeter
GUNTR1620EC

  • End-cut biopsy gun handpiece/needle
Kyphoplasty kirschner guide
BIOPSYBELL SRL
03.52.10.0466
In Commercial Distribution

  • 08033860020101 ()

  • Length: 460 Millimeter
  • Outer Diameter: 1.5 Millimeter
03.52.10.0466

  • Bone access channel kit
Kyphoplasty kirschner guide
BIOPSYBELL SRL
03.52.10.0465
In Commercial Distribution

  • 08033860020095 ()

  • Length: 460 Millimeter
  • Outer Diameter: 1.5 Millimeter
03.52.10.0465

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

  • 08033860020088 ()

  • Guidewire Diameter: 1.50 Millimeter
  • Guidewire Length: 460 Millimeter
03.52.10.0464

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

  • 08033860020071 ()

  • Guidewire Diameter: 1.50 Millimeter
  • Guidewire Length: 460 Millimeter
03.52.10.0463

  • Bone access channel kit
Kyphoplasty kirschner guide
BIOPSYBELL SRL
03.52.10.0470
In Commercial Distribution

  • 08033860020064 ()

  • Length: 600 Millimeter
  • Outer Diameter: 1.5 Millimeter
03.52.10.0470

  • Bone access channel kit
Kyphoplasty kirschner guide
BIOPSYBELL SRL
03.52.10.0469
In Commercial Distribution

  • 08033860020057 ()

  • Length: 600 Millimeter
  • Outer Diameter: 1.5 Millimeter
03.52.10.0469

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

  • 08033860020040 ()

  • Guidewire Diameter: 1.50 Millimeter
  • Guidewire Length: 600 Millimeter
03.52.10.0468

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

  • 08033860020033 ()

  • Guidewire Diameter: 1.50 Millimeter
  • Guidewire Length: 600 Millimeter
03.52.10.0467

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

  • 08033860019976 ()

  • Needle Gauge: 13 Gauge
  • Length: 150 Millimeter
ULSEC1315C

  • Bone marrow biopsy procedure kit
DISC DECOMPRESSION NEEDLE
BIOPSYBELL SRL
DISKOM
In Commercial Distribution

  • 08033860019747 ()

  • Length: 80 Millimeter
  • Needle Gauge: 19 Gauge
DKR1908CDFL10

  • Diskectomy system, percutaneous, automatic
DISC DECOMPRESSION NEEDLE
BIOPSYBELL SRL
DISKOM
In Commercial Distribution

  • 08033860019693 ()

  • Length: 160 Millimeter
  • Needle Gauge: 17 Gauge
DKR1716CDFL10

  • Diskectomy system, percutaneous, automatic
Fenestrated Screw Percutaneous Cannula
BIOPSYBELL SRL
SCREWFIX
In Commercial Distribution

  • 08033860019501 ()

  • Needle Gauge: 16 Gauge
  • Length: 250 Millimeter
03.51.10.0177

  • Orthopaedic cement preparation/delivery kit
Semiautomatic guillotine needle for soft-tissue biopsy
BIOPSYBELL SRL
SPEEDYBELL & INTRODUTTORE
In Commercial Distribution

  • 08033860019464 ()

  • Length: 70 Millimeter
  • Needle Gauge: 19 Gauge
SBTR1907EC

  • End-cut biopsy gun handpiece/needle
BONE ACCESS NEEDLE
BIOPSYBELL SRL
BONE ACCESS NEEDLE
In Commercial Distribution

  • 08033860019365 ()

  • Needle Gauge: 11 Gauge
  • Length: 120 Millimeter
BAN1112HCDTW

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

  • 08033860019174 ()

  • Needle Gauge: 11 Gauge
RESFG1128T

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

  • 08033860019167 ()

  • Needle Gauge: 11 Gauge
RESFG1128P

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

  • 08033860019112 ()
  • 08033860019105 ()

  • Needle Gauge: 08 Gauge
  • Outer Diameter: 3.70 Millimeter
RESDRI0812C

  • Orthopaedic cement preparation/delivery kit
KYPHOPLASTY FAST ACCESS BONE ACCESS KIT
BIOPSYBELL SRL
RENOVA SPINE FAST ACCESS SYSTEM
In Commercial Distribution

  • 08033860019013 ()

  • Needle Gauge: 11 Gauge
RES1112001V

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

  • 08033860018931 ()

  • Needle Gauge: 08 Gauge
RESWT0812C

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

  • 08033860018917 ()

  • Needle Gauge: 11 Gauge
RESOB1110T

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

  • 08033860018825 ()

  • Needle Gauge: 08 Gauge
RES0812001L

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

  • 08033860018467 ()

  • Length: 150 Millimeter
  • Needle Gauge: 17 Gauge
SBDTR1715EC

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

  • 08033860018443 ()

  • Length: 130 Millimeter
  • Needle Gauge: 17 Gauge
SBDTR1713EC

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

  • 08033860018429 ()

  • Needle Gauge: 17 Gauge
  • Length: 70 Millimeter
SBD1707EC

  • End-cut biopsy gun handpiece/needle
BONE ACCESS NEEDLE
BIOPSYBELL SRL
BONE ACCESS NEEDLE
In Commercial Distribution

  • 08033860017927 ()

  • Needle Gauge: 11 Gauge
  • Length: 150 Millimeter
BAN1115CDT

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

  • 08033860017781 ()

  • Length: 250 Millimeter
  • Needle Gauge: 16 Gauge
GUN1625EC-OS

  • End-cut biopsy gun handpiece/needle
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