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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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4.5mm Occipital Screw, 17mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-31-4517
Not in Commercial Distribution

  • 10889981034214 ()

  • 4.5mm, 17mm
16-31-4517

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Occipital Screw, 13mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-31-4513
Not in Commercial Distribution

  • 10889981034177 ()

  • 4.5mm, 13mm
16-31-4513

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Occipital Screw, 7mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-31-4507
Not in Commercial Distribution

  • 10889981034115 ()

  • 4.5mm, 7mm
16-31-4507

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Occipital Screw, 6mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-31-4506
Not in Commercial Distribution

  • 10889981034108 ()

  • 4.5mm, 6mm
16-31-4506

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Occipital Screw, 12mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-31-4012
Not in Commercial Distribution

  • 10889981034030 ()

  • 4.0mm, 12mm
16-31-4012

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Occipital Screw, 11mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-31-4011
Not in Commercial Distribution

  • 10889981034023 ()

  • 4.0mm, 11mm
16-31-4011

  • Bone-screw internal spinal fixation system, non-sterile
Offset Hook (left) - medium. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-21-1805
In Commercial Distribution

  • 10889981033842 ()

  • medium
16-21-1805

  • Bone-screw internal spinal fixation system, non-sterile
Closed Lateral Offset Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-24-0011
Not in Commercial Distribution

  • 10889981033774 ()
16-24-0011

  • Bone-screw internal spinal fixation system, non-sterile
Inline 3.5mm to 5.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-5520
In Commercial Distribution

  • 10889981033736 ()

  • 3.5mm to 5.5mm
16-23-5520

  • Bone-screw internal spinal fixation system, non-sterile
PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
PERIGEN INC.
2019 Rev 1.02
In Commercial Distribution

  • 00862095000491 ()


  • Obstetrics information system application software
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