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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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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
BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-12P
In Commercial Distribution

  • 00816125026067 ()
ZS8213-12P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-10P
In Commercial Distribution

  • 00816125026050 ()
ZS8213-10P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-6P
In Commercial Distribution

  • 00816125026043 ()
ZS8213-6P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-5P
In Commercial Distribution

  • 00816125026036 ()
ZS8213-5P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty 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. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-2P
In Commercial Distribution

  • 00816125026029 ()
ZS8213-2P

  • Bone matrix implant, synthetic, non-antimicrobial
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