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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 Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-ATEM148POS
In Commercial Distribution

  • 05712821011992 ()
CAS-ATEM148POS

  • Dental prosthesis/implant abutment screw
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
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
AGHA24
In Commercial Distribution

  • 10850828007128 ()
  • 00850828007121 ()


  • 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
AGHA22
In Commercial Distribution

  • 10850828007111 ()
  • 00850828007114 ()


  • 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
AGHA12
In Commercial Distribution

  • 10850828007104 ()
  • 00850828007107 ()


  • Nerve guide, animal-derived
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
Elutia Med LLC
CMCV-060-402
In Commercial Distribution

  • 10859389005017 ()
  • 00859389005010 ()

  • Width: 7.0 Centimeter
  • Height: 15.0 Centimeter


  • Cardiovascular patch, animal-derived
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
Elutia Med LLC
CMCV-059-401
In Commercial Distribution

  • 00859389005003 ()
  • 10859389005000 ()

  • Height: 10 Centimeter
  • Width: 7 Centimeter


  • Cardiovascular patch, animal-derived
PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (1 mL)
3-D MATRIX INC.
651-007
In Commercial Distribution

  • 00860001820843 ()
651-007

  • Intranasal splint, biodegradable
PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)
3-D MATRIX INC.
651-008
In Commercial Distribution

  • 00860001820836 ()


  • Intranasal splint, biodegradable
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