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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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HALO, 1203-5 VEST PED00, ACRYLIC LINER, 1211-1 X-SMALL OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-11 TRACTION BAIL
PMT CORPORATION
1211-002
In Commercial Distribution

  • 00650551110279 ()
1211-002

  • Cervical spine immobilization system, single-use
HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 1208-1 X-LARGE OPEN BACK RING, 1206-32 HEADBLOCKS, 1206-11 TRACTION BAIL
PMT CORPORATION
1208-419
In Commercial Distribution

  • 00650551110248 ()
1208-419

  • Cervical spine immobilization system, single-use
Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. K223640: Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. K231708: Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also provides tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and has sufficient mechanical strength to hold sutures.
AXOGEN CORPORATION
AGHA48
In Commercial Distribution

  • 10850828007142 ()
  • 00850828007145 ()


  • Nerve guide, animal-derived
Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. K223640: Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. K231708: Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also provides tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and has sufficient mechanical strength to hold sutures.
AXOGEN CORPORATION
AGHA36
In Commercial Distribution

  • 10850828007135 ()
  • 00850828007138 ()


  • Nerve guide, animal-derived
HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 1208-1 LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-11 TRACTION BAIL
PMT CORPORATION
1208-415
In Commercial Distribution

  • 00650551110200 ()
1208-415

  • Cervical spine immobilization system, single-use
Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. K223640: Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. K231708: Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also provides tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and has sufficient mechanical strength to hold sutures.
AXOGEN CORPORATION
AGHA22
In Commercial Distribution

  • 10850828007111 ()
  • 00850828007114 ()


  • Nerve guide, animal-derived
HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 1208-1 MEDIUM OPEN BACK RING, 1206-32 HEADBLOCKS, 1206-11 TRACTION BAIL
PMT CORPORATION
1208-413
In Commercial Distribution

  • 00650551110187 ()
1208-413

  • Cervical spine immobilization system, single-use
HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 1208-1 MEDIUM OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-11 TRACTION BAIL
PMT CORPORATION
1208-412
In Commercial Distribution

  • 00650551110170 ()
1208-412

  • Cervical spine immobilization system, single-use
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
HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 1208-1 SMALL OPEN BACK RING, 1206-32 HEADBLOCKS, 1206-11 TRACTION BAIL
PMT CORPORATION
1208-410
In Commercial Distribution

  • 00650551110156 ()
1208-410

  • Cervical spine immobilization system, single-use
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