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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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UCR - 10381780011835

Polyaxial Screw 5.5 x 30 mm
Seaspine, Inc.
10-5530
Not in Commercial Distribution

  • M5561055301 ()
  • 10381780011835 ()

  • 5.5 x 30 mm
10-5530

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

UCR - 10381780011804

Polyaxial Screw 4.75 x 30 mm
Seaspine, Inc.
10-4730
Not in Commercial Distribution

  • M5561047301 ()
  • 10381780011804 ()

  • 4.75 x 30 mm
10-4730

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

UCR - 10381780000723

Polyaxial Screw 8.0 x 30 mm
Seaspine, Inc.
10-8030
Not in Commercial Distribution

  • M5561080301 ()
  • 10381780000723 ()

  • 8.0 x 30 mm
10-8030

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

UCR - 10381780000716

Polyaxial Screw 6.0 x 30 mm
Seaspine, Inc.
10-6030
Not in Commercial Distribution

  • M5561060301 ()
  • 10381780000716 ()

  • 6.0 x 30 mm
10-6030

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

Malibu - 10381780023005

UNI-PLANAR DLTA SCREW,6.5 X 30
Seaspine, Inc.
69-6530
Not in Commercial Distribution

  • M5566965301 ()
  • 10381780023005 ()

  • 6.5 X 30
69-6530

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

Malibu - 10381780022961

UNI-PLANAR DLTA SCREW,5.5 X 30
Seaspine, Inc.
69-5530
Not in Commercial Distribution

  • M5566955301 ()
  • 10381780022961 ()

  • 5.5 X 30
69-5530

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

Malibu - 10381780022923

UNI-PLANAR DLTA SCREW,4.5 X 30
Seaspine, Inc.
69-4530
Not in Commercial Distribution

  • M5566945301 ()
  • 10381780022923 ()

  • 4.5 X 30
69-4530

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

Integra® Miltex® - 10381780481904

Union Broach® Reamers #30 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12186
Not in Commercial Distribution

  • H834012121861 ()
  • 10381780481904 ()
  • 00381780481907 ()
012-12186

  • Manual endodontic file/rasp, single-use

Integra® Miltex® - 10381780481621

Union Broach® Reamers #30 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12007
Not in Commercial Distribution

  • H834012120071 ()
  • 10381780481621 ()
  • 00381780481624 ()
012-12007

  • Manual endodontic file/rasp, single-use

Integra® Miltex® - 10381780481454

Sharpie® Hedstrom Files #30 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-11183
Not in Commercial Distribution

  • H834012111831 ()
  • 10381780481454 ()
  • 00381780481457 ()
012-11183

  • Manual endodontic file/rasp, single-use
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