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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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Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. Bi-Ostetic is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The Bi-Ostetic granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
BiO-02G
In Commercial Distribution

  • 00858418003003 ()
BiO-02G

  • Bone matrix implant, synthetic, non-antimicrobial
The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
AXOGEN CORPORATION
AGT720
In Commercial Distribution

  • 00850828007091 ()
  • 10850828007098 ()


  • Nerve guide, animal-derived
The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
AXOGEN CORPORATION
AGT620
In Commercial Distribution

  • 00850828007084 ()
  • 10850828007081 ()


  • Nerve guide, animal-derived
The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
AXOGEN CORPORATION
AGT520
In Commercial Distribution

  • 00850828007077 ()
  • 10850828007074 ()


  • Nerve guide, animal-derived
The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
AXOGEN CORPORATION
AGT415
In Commercial Distribution

  • 00850828007060 ()
  • 10850828007067 ()


  • Nerve guide, animal-derived
The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
AXOGEN CORPORATION
AGT315
In Commercial Distribution

  • 00850828007053 ()
  • 10850828007050 ()


  • Nerve guide, animal-derived
The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
AXOGEN CORPORATION
AGT215
In Commercial Distribution

  • 00850828007046 ()
  • 10850828007043 ()


  • Nerve guide, animal-derived
Granule Size: 1-6mm Volume: 30cc BiSyntek Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. BiSyntek Granules is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The Bi-Ostetic granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS7-G16-60
In Commercial Distribution

  • 00816125025640 ()
ZS7-G16-60

  • Bone matrix implant, synthetic, non-antimicrobial
Granule Size: 1-6mm Volume: 15cc BiSyntek Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. BiSyntek Granules is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The Bi-Ostetic granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS7-G16-15
In Commercial Distribution

  • 00816125025619 ()
ZS7-G16-15

  • Bone matrix implant, synthetic, non-antimicrobial
Granule Size: 1-3mm Volume: 10cc BiSyntek Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. BiSyntek Granules is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The Bi-Ostetic granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS7-G13-10
In Commercial Distribution

  • 00816125025602 ()
ZS7-G13-10

  • Bone matrix implant, synthetic, non-antimicrobial
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