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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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HELICOLL - 10860000744413

HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x4 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC2x4
In Commercial Distribution

  • 00860000744416 ()
  • 10860000744413 ()
HC2x4

  • Collagen wound matrix dressing

HELICOLL - 10860000744406

HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x2 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC2x2
In Commercial Distribution

  • 00860000744409 ()
  • 10860000744406 ()
HC2x2

  • Collagen wound matrix dressing

FS3 Facet Screw Spinal System - 00190837041519

Cannulated Reamer, Ø6.25mm X 16mm, Tapered Tip
Life Spine, Inc.
2018-0046
In Commercial Distribution

  • 00190837041519 ()
2018-0046

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

FS3 Facet Screw Spinal System - 00190837041502

FS3 Dilation Tube, #4, Radiopaque
Life Spine, Inc.
2017-0195
In Commercial Distribution

  • 00190837041502 ()
2017-0195

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

FS3 Facet Screw Spinal System - 00190837041496

FS3 Stab-N-Grab Driver, T20
Life Spine, Inc.
2017-0121
In Commercial Distribution

  • 00190837041496 ()
2017-0121

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

FS3 Facet Screw Spinal System - 00190837041489

Facet Screw Driver, Mid Length with Flats
Life Spine, Inc.
2017-0090
In Commercial Distribution

  • 00190837041489 ()
2017-0090

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

FS3 Facet Screw Spinal System - 00190837041472

Cannulated Reamer, 6.25mm x 16mm, Tapered Tip
Life Spine, Inc.
2017-0017
In Commercial Distribution

  • 00190837041472 ()
2017-0017

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

FS3 Facet Screw Spinal System - 00190837041465

Cannulated Step Drill
Life Spine, Inc.
2017-0016
In Commercial Distribution

  • 00190837041465 ()
2017-0016

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

FS3 Facet Screw Spinal System - 00190837041458

FS3 Cannulated Drill, AO Drive, Short
Life Spine, Inc.
2017-0002
In Commercial Distribution

  • 00190837041458 ()
2017-0002

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

FS3 Facet Screw Spinal System - 00190837041441

FS3 Dilation Tube, #4, with Teeth
Life Spine, Inc.
2017-0001
In Commercial Distribution

  • 00190837041441 ()
2017-0001

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