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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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Nerve Tape® - G517NT30140

Nerve Tape® is a surgical implant designed to align and connect peripheral nerves. Nerve Tape® is designed to be an interface between the nerve and the surrounding tissue. Nerve Tape® is comprised of an extracellular matrix (ECM), which is fully remodeled during the healing process, and Nitinol microhooks, which bind coapted nerve ends together. When hydrated, Nerve Tape® is easy to handle, soft, pliable, nonfriable, and porous. Nerve Tape® has sufficient mechanical strength to hold the ends of the nerve together. Nerve Tape® is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
Biocircuit Technologies, Inc.
NT30-14
In Commercial Distribution

  • G517NT30140 ()

  • Lumen/Inner Diameter: 3.0 Millimeter
NT30-14

  • Nerve guide, metal/animal-derived

Nerve Tape® - G517NT20140

Nerve Tape® is a surgical implant designed to align and connect peripheral nerves. Nerve Tape® is designed to be an interface between the nerve and the surrounding tissue. Nerve Tape® is comprised of an extracellular matrix (ECM), which is fully remodeled during the healing process, and Nitinol microhooks, which bind coapted nerve ends together. When hydrated, Nerve Tape® is easy to handle, soft, pliable, nonfriable, and porous. Nerve Tape® has sufficient mechanical strength to hold the ends of the nerve together. Nerve Tape® is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
Biocircuit Technologies, Inc.
NT20-14
In Commercial Distribution

  • G517NT20140 ()

  • Lumen/Inner Diameter: 2.0 Millimeter
NT20-14

  • Nerve guide, metal/animal-derived

Nerve Tape® - G517NT15140

Nerve Tape® is a surgical implant designed to align and connect peripheral nerves. Nerve Tape® is designed to be an interface between the nerve and the surrounding tissue. Nerve Tape® is comprised of an extracellular matrix (ECM), which is fully remodeled during the healing process, and Nitinol microhooks, which bind coapted nerve ends together. When hydrated, Nerve Tape® is easy to handle, soft, pliable, nonfriable, and porous. Nerve Tape® has sufficient mechanical strength to hold the ends of the nerve together. Nerve Tape® is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
Biocircuit Technologies, Inc.
NT15-14
In Commercial Distribution

  • G517NT15140 ()

  • Lumen/Inner Diameter: 1.5 Millimeter
NT15-14

  • Nerve guide, metal/animal-derived

Stimulan® DS - 50601557110584

Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single patient use. The kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together, the resultant paste is to be injected or digitally packed into open bone/gap to cure insitu. The biodegradable, radiopaque mixture is resorbed in approximately 30-60 days when used in accordance with the device labelling. Stimulan® is manufactured from synthetic implant grade calcium sulfate dihydrate (CaS04, 2H20) that resporbs and is replaced with bone during the healing process. Also as the bone void filler is biodegradable and biocompatible; it may be used at an infected site.
BIOCOMPOSITES LTD
640-005
Not in Commercial Distribution

  • 50601557110584 ()

  • 5cc
640-005

  • Synthetic bone graft

Stimulan® DS - 15060155711055

Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single patient use. The kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together, the resultant paste is to be injected or digitally packed into open bone/gap to cure insitu. The biodegradable, radiopaque mixture is resorbed in approximately 30-60 days when used in accordance with the device labelling. Stimulan® is manufactured from synthetic implant grade calcium sulfate dihydrate (CaS04, 2H20) that resporbs and is replaced with bone during the healing process. Also as the bone void filler is biodegradable and biocompatible; it may be used at an infected site.
BIOCOMPOSITES LTD
640-005
In Commercial Distribution


  • 5cc
640-005

  • Synthetic bone graft

Nerve Tape® - G517NT70220

Nerve Tape® is a surgical implant designed to align and connect peripheral nerves. Nerve Tape® is designed to be an interface between the nerve and the surrounding tissue. Nerve Tape® is comprised of an extracellular matrix (ECM), which is fully remodeled during the healing process, and Nitinol microhooks, which bind coapted nerve ends together. When hydrated, Nerve Tape® is easy to handle, soft, pliable, nonfriable, and porous. Nerve Tape® has sufficient mechanical strength to hold the ends of the nerve together. Nerve Tape® is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
Biocircuit Technologies, Inc.
NT70-22
In Commercial Distribution

  • G517NT70220 ()

  • Lumen/Inner Diameter: 7.0 Millimeter
NT70-22

  • Nerve guide, metal/animal-derived

CODMAN® BACTISEAL® - 10381780537137

CODMAN® BACTISEAL® 23cm Ventricular Catheter Set MR Conditional Contents: Ventricular Catheter 23cm (1), Right Angle Adapter (1), Luer Connector (1), Cap (1), Catheter Anchoring Clip (1); Additional Contents: Stylet (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
NS5115
In Commercial Distribution

  • 10381780537137 ()

  • Catheter Length: 23 Centimeter
NS5115

  • Intracerebral infusion/drainage catheter, long-term

CODMAN® BACTISEAL® - 10381780537120

CODMAN® BACTISEAL® Catheters MR Conditional Contents: Ventricular Catheter 15cm (1), Right Angle Adapter (1); Additional Contents: Stylet (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
NS5075
In Commercial Distribution

  • 10381780537120 ()

  • Catheter Length: 15 Centimeter
NS5075

  • Intracerebral infusion/drainage catheter, long-term
  • Peritoneal/atrial cerebrospinal fluid catheter

CODMAN® BACTISEAL® - 10381780537113

CODMAN® BACTISEAL® Catheter MR Conditional Contents: Peritoneal Catheter 120cm (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
NS5074
In Commercial Distribution

  • 10381780537113 ()

  • Catheter Length: 120 Centimeter
NS5074

  • Peritoneal/atrial cerebrospinal fluid catheter

CODMAN® BACTISEAL® - 10381780537106

CODMAN® BACTISEAL® Large Ventricular Catheter MR Conditional Contents: Ventricular Catheter 15cm (1), Right Angle Adapter (1); Additional Contents: Stylet (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
NS5073
In Commercial Distribution

  • 10381780537106 ()

  • Catheter Length: 15 Centimeter
NS5073

  • Intracerebral infusion/drainage catheter, long-term
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