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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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Frontier V6 Mid Wheel Drive Electric Wheelchair
RED MILAWA PTY. LTD.
V6
In Commercial Distribution

  • 09356399000024 ()
Frontier V6

  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Frontier V4 Front Wheel Drive Electric Wheelchair
RED MILAWA PTY. LTD.
V4 FWD
In Commercial Distribution

  • 09356399000017 ()
Frontier V4 FWD

  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Frontier V4 Rear Wheel Drive Electric Wheelchair
RED MILAWA PTY. LTD.
V4 RWD
In Commercial Distribution

  • 09356399000000 ()
Frontier V4 RWD

  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Circumplast single use infant male circumcision device, size 9.5mm
EMBOSS MEDICAL LIMITED
Circumplast 9.5mm
In Commercial Distribution

  • 09351108000005 ()
  • 09351108000098 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
CIRC95MM

  • Circumcision clamp, single-use
Novel SD, 28mm L, 9mm W, 10mm H, Titanium
ALPHATEC SPINE, INC.
64807-010
In Commercial Distribution

  • 00844856019249 ()

  • Height: 10 Millimeter
  • Length: 28 Millimeter
  • Width: 9 Millimeter


  • Metallic spinal fusion cage, non-sterile
Novel SD, 25mm L, 9mm W, 11mm H, Titanium
ALPHATEC SPINE, INC.
64805-011
In Commercial Distribution

  • 00844856019188 ()

  • Width: 9 Millimeter
  • Height: 11 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal fusion cage, non-sterile
Novel LCC Titanium, 12x20x12mm, 5deg
ALPHATEC SPINE, INC.
64104-112
In Commercial Distribution

  • 00844856008564 ()

  • Angle: 5 degree
  • Height: 12 Millimeter
  • Length: 20 Millimeter
  • Width: 12 Millimeter


  • Metallic spinal fusion cage, non-sterile
Cancellous Bone Screw
CONSENSUS ORTHOPEDICS, INC.
0013-1-6550
Not in Commercial Distribution

  • 00844588000447 ()

  • Outer Diameter: 50 Millimeter
0013-1-6550

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Cancellous Bone Screw
CONSENSUS ORTHOPEDICS, INC.
0013-1-6545
Not in Commercial Distribution

  • 00844588000430 ()

  • Outer Diameter: 45 Millimeter
0013-1-6545

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Cancellous Bone Screw
CONSENSUS ORTHOPEDICS, INC.
0013-1-6540
Not in Commercial Distribution

  • 00844588000423 ()

  • Outer Diameter: 40 Millimeter
0013-1-6540

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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