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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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Kahook Dual Blade Glide
NEW WORLD MEDICAL, INCORPORATED
KDB Glide
In Commercial Distribution

  • 00892064002003 ()
10-0065

  • Ophthalmic knife, single-use
VIA360 Surgical System
NEW WORLD MEDICAL, INCORPORATED
VIA360
In Commercial Distribution

  • 00892064002362 ()
10-0615

  • Ophthalmic knife, single-use
  • Ophthalmic surgical irrigation/infusion/aspiration handle, single-use
Porous Polyethylene Glaucoma Drainage Device
NEW WORLD MEDICAL, INCORPORATED
M4
Not in Commercial Distribution

  • 00892064002270 ()

  • Area/Surface Area: 160 Square millimeter
M4

  • Eye valve
Streamline
NEW WORLD MEDICAL, INCORPORATED
10-0066
In Commercial Distribution

  • 00892064002102 ()
10-0066

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST250
In Commercial Distribution

  • 00892064002089 ()

  • Area/Surface Area: 250 Square millimeter
10-0609

  • Glaucoma shunt, tubular, non-animal-derived
Streamline
NEW WORLD MEDICAL, INCORPORATED
10-0066
Not in Commercial Distribution

  • 00892064002010 ()
10-0066

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Poly-Axial Screw, Cannulated, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022563 ()
3PCS55-25-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Cannulated, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022556 ()
3PCS55-25

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022549 ()
3PR55-25

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022532 ()
3PS55-25

  • Bone-screw internal spinal fixation system, non-sterile
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