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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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NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSorb® technology that supports the adherence and proliferation of the vital cells involved in new tissue regeneration. NovoSorb® SynPath™ is a non-toxic, porous network of biodegradable synthetic polymers that act as a support template for cellular repair. The matrix is fenestrated to allow excess exudate from the wound to pass through to a secondary absorbent layer to prevent maceration. As the matrix integrates into the wound bed, it supports the creation of a neodermal structure.
POLYNOVO BIOMATERIALS PTY LIMITED
SYN-0304
In Commercial Distribution

  • 09349155001137 ()
  • 09349155001144 ()
  • 09349155001151 ()

  • Length: 3 Centimeter
  • Width: 4 Centimeter


  • Synthetic wound matrix dressing
NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSorb® technology that supports the adherence and proliferation of the vital cells involved in new tissue regeneration. NovoSorb® SynPath™ is a non-toxic, porous network of biodegradable synthetic polymers that act as a support template for cellular repair. The matrix is fenestrated to allow excess exudate from the wound to pass through to a secondary absorbent layer to prevent maceration. As the matrix integrates into the wound bed, it supports the creation of a neodermal structure.
POLYNOVO BIOMATERIALS PTY LIMITED
SYN-1010
In Commercial Distribution

  • 09349155000239 ()
  • 09349155000246 ()
  • 09349155000253 ()

  • Length: 10 Centimeter
  • Width: 10 Centimeter


  • Synthetic wound matrix dressing
"H&H" Wound Gel (Sterile) is a transparent gel dressing with an amorphous structure, suitable for irregularly shaped wounds. The formulation is designed to achieve isotonicity, allowing the gel to cover the wound bed, providing a moist wound healing environment, and promoting the migration of new epidermal cells. Carboxymethyl cellulose, combined with glycerol and hyaluronic acid, not only helps absorb wound exudate and blood but also forms a moist gel protective layer on the wound bed, providing an optimal moist healing environment while reducing the risk of infection by acting as a barrier to foreign materials.
TRONJEN MEDICAL TECHNOLOGY INC.
WG0030
In Commercial Distribution

  • 04719884331402 ()
  • 04719884331426 ()

  • Total Volume: 30 Milliliter
WG0030

  • Wound hydrogel dressing, non-antimicrobial
OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector. Indications for Use: 1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.
Infraredx, Inc.
YOK0B
In Commercial Distribution

  • 04543660022341 ()
  • 14543660022348 ()


  • Haemostasis valve
OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube. Indications for Use: 1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.
Infraredx, Inc.
YOK0E
In Commercial Distribution

  • 04543660022358 ()
  • 14543660022355 ()


  • Haemostasis valve
OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. Indications for Use: 1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.
Infraredx, Inc.
YOK0A
In Commercial Distribution

  • 04543660022334 ()
  • 14543660022331 ()


  • Haemostasis valve
HA-TCP-Bioglass Sponge is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive. HA-TCP-Bioglass Sponge is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. HA-TCP-Bioglass Sponge must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ARM-TCP-BA-12
In Commercial Distribution

  • 00816125023868 ()
ARM-TCP-BA-12

  • Bone matrix implant, synthetic, non-antimicrobial
HA-TCP-Bioglass Sponge is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive. HA-TCP-Bioglass Sponge is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. HA-TCP-Bioglass Sponge must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AMWS-TCP-BA-12
In Commercial Distribution

  • 00816125023691 ()
AMWS-TCP-BA-12

  • Bone matrix implant, synthetic, non-antimicrobial
OptiFuse BA is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive. OptiFuse BA is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. OptiFuse BA must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
7888-0125
In Commercial Distribution

  • 00816125023615 ()
7888-0125

  • Bone matrix implant, synthetic, non-antimicrobial
OptiFuse BA is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive. OptiFuse BA is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. OptiFuse BA must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
7888-0063
In Commercial Distribution

  • 00816125023608 ()
7888-0063

  • Bone matrix implant, synthetic, non-antimicrobial
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