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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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Prodigy Value Pack 12 x Item # 073200; 4 x Item # 07120
Prodigy Diabetes Care, LLC
075150
In Commercial Distribution

  • 00384840751507 ()
075150

  • Home-use/point-of-care blood glucose monitoring system IVD
  • Glucose IVD, kit, electrometry
  • Manual blood lancing device, reusable
Prodigy Combo Pre-Pack 20 x Item # 073200; 5 x Item # 07120
Prodigy Diabetes Care, LLC
075100
In Commercial Distribution

  • 00384840751002 ()
075100

  • Manual blood lancing device, reusable
  • Glucose IVD, kit, electrometry
  • Home-use/point-of-care blood glucose monitoring system IVD
Prodigy Voice Blood Glucose Monitoring System (KIT)
Prodigy Diabetes Care, LLC
071950
In Commercial Distribution

  • 00384841519007 ()
  • 00384843719504 ()
  • 00384840719507 ()
071950

  • Manual blood lancing device, reusable
  • Glucose IVD, control
  • Glucose IVD, kit, electrometry
  • Home-use/point-of-care blood glucose monitoring system IVD
Prodigy Voice Blood Glucose Monitoring System (KIT)
Prodigy Diabetes Care, LLC
051900
In Commercial Distribution

  • 00384841519007 ()
  • 00384843519005 ()
  • 00384840519008 ()
051900

  • Manual blood lancing device, reusable
  • Glucose IVD, control
  • Glucose IVD, kit, electrometry
  • Home-use/point-of-care blood glucose monitoring system IVD
Repose Extra Small Footprotector Plus (Bulk Pack 10) with Pump
Frontier Therapeutics Inc
6550100
In Commercial Distribution

  • 05056279302432 ()


  • Heel protector
SPRING CLIP,SAFEJAW 6MM STER FOGARTY,LATEX FREE 10/CA
Edwards Lifesciences LLC
CSAFE6
In Commercial Distribution

  • 00690103044164 ()
  • 70690103044163 ()

  • MAXIMUM JAW OPENING: 6MM
CSAFE6

  • Vascular clamp, single-use
LATERAL IMPLANT, LORDOTIC, 8mm X 23mm X 50mm X 10°
Seaspine Orthopedics Corporation
31-37-0850-10
In Commercial Distribution

  • 10889981047955 ()

  • 8mm X 23mm X 50mm X 10°
31-37-0850-10

  • Vertebral body prosthesis, non-sterile
LATERAL IMPLANT, LORDOTIC, 10mm X 23mm X 50mm X 10°
Seaspine Orthopedics Corporation
31-23-1050-10
In Commercial Distribution

  • 10889981046651 ()

  • 10mm x 23mm x 50mm x 10°
31-23-1050-10

  • Vertebral body prosthesis, non-sterile
Redondo Implant, 30mm x 24mm x 14mm, 10 Deg Lordotic
Seaspine Orthopedics Corporation
36-1014
In Commercial Distribution

  • 10889981044114 ()

  • 30mm x 24mm x 14mm, 10°
36-1014

  • Vertebral body prosthesis, non-sterile
Redondo Implant, 30mm x 24mm x 12mm, 10 Deg Lordotic
Seaspine Orthopedics Corporation
36-1012
In Commercial Distribution

  • 10889981044107 ()

  • 30mm x 24mm x 12mm, 10°
36-1012

  • Vertebral body prosthesis, non-sterile
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