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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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HemoMix 3 - 08033928530016

HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached (Basic version))
DELCON SRL
HMIX3.485
In Commercial Distribution

  • 08033928530016 ()


  • Blood donation rocker

BIOPSYBELL - 08033860044954

OsteoPearl™ Bone Filler, 8G Orthopedic procedure with Biological Allograft Chain
BIOPSYBELL SRL
OSTEOPEARL™ BONE FILLER 8G
In Commercial Distribution

  • 08033860044961 ()
  • 08033860044954 ()

  • Needle Gauge: 08 Gauge
  • Length: 182 Millimeter
100.438

  • Bone graft delivery kit

BIOPSYBELL - 08033860044930

OsteoPearl™ Drill, 8G Orthopedic procedure with Biological Allograft Chain
BIOPSYBELL SRL
OSTEOPEARL™ DRILL 8G
In Commercial Distribution

  • 08033860044947 ()
  • 08033860044930 ()

  • Needle Gauge: 08 Gauge
  • Length: 182 Millimeter
100.436

  • Bone graft delivery kit

BIOPSYBELL - 08033860044916

OsteoPearl™ Access Cannula & Beveled Tip Trocar, 8G Orthopedic procedure with Biological Allograft Chain
BIOPSYBELL SRL
OSTEOPEARL™ ACCESS CANNULA & BEVELED TIP TROCAR 8G
In Commercial Distribution

  • 08033860044923 ()
  • 08033860044916 ()

  • Needle Gauge: 08 Gauge
  • Length: 120 Millimeter
100.434

  • Bone graft delivery kit

BIOPSYBELL - 08033860044893

OsteoPearl™ Access Cannula & Diamond Tip Trocar, 8G for Orthopedic procedure with Biological Allograft Chain
BIOPSYBELL SRL
OSTEOPEARL™ ACCESS CANNULA & DIAMOND TIP TROCAR 8G
In Commercial Distribution

  • 08033860044909 ()
  • 08033860044893 ()

  • Needle Gauge: 08 Gauge
  • Length: 120 Millimeter
100.432

  • Bone graft delivery kit

BIOPSYBELL - 08033860044756

BONE ACCESS NEEDLE
BIOPSYBELL SRL
BONE ACCESS NEEDLE
In Commercial Distribution

  • 08033860044763 ()
  • 08033860044756 ()

  • Needle Gauge: 08 Gauge
  • Length: 150 Millimeter
BAN0815HCDBPW

  • Bone access channel kit

BIOPSYBELL - 08033860044732

BONE ACCESS NEEDLE
BIOPSYBELL SRL
BONE ACCESS NEEDLE
In Commercial Distribution

  • 08033860044749 ()
  • 08033860044732 ()

  • Needle Gauge: 08 Gauge
  • Length: 150 Millimeter
BAN0815HCDTW

  • Bone access channel kit

BIOPSYBELL - 08033860043643

KYPHOPLASTY WORKING CANNULA AND BEVEL TIP
BIOPSYBELL SRL
RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP
In Commercial Distribution

  • 08033860043643 ()

  • Needle Gauge: 08 Gauge
  • Length: 120 Millimeter
RESWB0812C-US

  • Bone access channel kit

BIOPSYBELL - 08033860043438

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

  • 08033860043438 ()

  • Needle Gauge: 9 Gauge
  • Length: 150 Millimeter
ULSEC0915C

  • Bone marrow biopsy procedure kit

BIOPSYBELL - 08033860043421

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

  • 08033860043421 ()

  • Needle Gauge: 9 Gauge
  • Length: 100 Millimeter
ULSEC0910C

  • Bone marrow biopsy procedure kit
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