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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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The subjected Spacer of 2.5 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
3
In Commercial Distribution

  • 07290019421191 ()

  • Height: 2.5 Millimeter
ZF-30MX-25TU

  • Spinal bone screw, non-bioabsorbable
The subjected Spacer of 1.5 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
3
In Commercial Distribution

  • 07290019421177 ()

  • Height: 1.5 Millimeter
ZF-30MX-15TU

  • Spinal bone screw, non-bioabsorbable
The subjected Spacer of 2.0 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
3
In Commercial Distribution

  • 07290019421184 ()

  • Height: 2.0 Millimeter
ZF-30MX-20TU

  • Spinal bone screw, non-bioabsorbable
Access Needle, 11 GA
Life Spine, Inc.
144-020
In Commercial Distribution

  • 00190837041236 ()
144-020

  • Bone access cannula
Access Needle Sheath
Life Spine, Inc.
144-018
In Commercial Distribution

  • 00190837041212 ()
144-018

  • Bone access cannula
Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with antibacterial ionic silver particles. The dressing contains 0.35~0.40mg/cm3 (17.3~20.1 mg/100cm2) of ionic silver. The high absorbency, along with antibacterial properties, qualify Areza Medical Silver Foam Dressing as a very useful dressing indicated for exudate absorption and the management of partial to full-thickness wounds. The dressing provides a proper moist wound-healing environment.
ADVANCED MEDICAL ASSOCIATES, LLC
AGF42510
In Commercial Distribution

  • 00850021481865 ()
  • 00850021481742 ()
  • 00850021481858 ()
  • 00850021481346 ()

  • Width: 4.25 Inch
  • Length: 4.25 Inch
  • Height: 5 Millimeter
AGF42510

  • Exudate-absorbent dressing, non-gel, antimicrobial
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield® Spiral is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
80 mm Circular
In Commercial Distribution

  • 05694310965224 ()
  • 05694310965217 ()
  • 05694310965231 ()

  • Outer Diameter: 80 Millimeter
50215L54B0D

  • Collagen wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield® Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
15mm Circular
In Commercial Distribution

  • 05694310965194 ()
  • 05694310965187 ()
  • 05694310965200 ()

  • Outer Diameter: 15 Millimeter
50215H50B0D

  • Collagen wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
KERECIS hf.
10 x 18 cm fish skin
In Commercial Distribution

  • 05694310965170 ()
  • 05694310965163 ()

  • Height: 10 Centimeter
  • Width: 18 Centimeter
50214F56D0D

  • Collagen wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
KERECIS hf.
6 x 14 cm fish skin
In Commercial Distribution

  • 05694310965156 ()
  • 05694310965149 ()

  • Width: 14 Centimeter
  • Height: 6 Centimeter
50214F55D0D

  • Collagen wound matrix dressing
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