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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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ArchiMIS - 00857373006111

Avitus® ArchiMIS Precision Autograft Delivery (Ø4.0mm, 120mm system)
AVITUS ORTHOPAEDICS, INC.
AD-1ch-4.0-120
In Commercial Distribution

  • 00857373006111 ()
AD-1ch-4.0-120

  • Bone grafting cannula

Avitus Bone Harvester - 00857373006074

Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.
AVITUS ORTHOPAEDICS, INC.
BH-220
In Commercial Distribution

  • 00857373006074 ()
BH-220

  • Bone graft harvesting filter
  • Neurosurgical curette, single-use

Avitus Pilot Hole Creator, Disposable - 11mm - 00857373006067

Disposable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone.
AVITUS ORTHOPAEDICS, INC.
PC-100
In Commercial Distribution

  • 00857373006067 ()
PC-100

  • Bone awl, single-use

Avitus Bone Harvester - 00857373006050

Sterile, disposable surgical instrument with 8mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.
AVITUS ORTHOPAEDICS, INC.
BH-110
In Commercial Distribution

  • 00857373006050 ()
BH-110

  • Bone graft harvesting filter
  • Neurosurgical curette, single-use

Avitus Bone Harvester - 00857373006036

Sterile, disposable surgical instrument with 5mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.
AVITUS ORTHOPAEDICS, INC.
BH-210
In Commercial Distribution

  • 00857373006036 ()
BH-210

  • Bone graft harvesting filter
  • Neurosurgical curette, single-use

Avitus Bone Harvester - 00857373006029

Filter Accessory for REF: BH8 ONLY
AVITUS ORTHOPAEDICS, INC.
FI-100
In Commercial Distribution

  • 00857373006029 ()
FI-100

  • Bone graft harvesting filter

Avitus Pilot Hole Creator, Disposable - 8mm - 00857373006012

Disposable surgical instrument with 8mm tip for manually cutting a hole into bone allowing access to cancellous bone.
AVITUS ORTHOPAEDICS, INC.
PC-200
In Commercial Distribution

  • 00857373006012 ()
PC-200

  • Bone awl, single-use

Avitus Bone Harvester - 00857373006005

A manual surgical instrument that cuts cancellous bone by manual actuation of the 8mm cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an ID of 6–10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure between 150 mmHg and 300 mmHg. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bone reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone graft can be retrieved from the handle.
AVITUS ORTHOPAEDICS, INC.
BH8
In Commercial Distribution

  • 00857373006005 ()
BH8

  • Bone graft harvesting filter
  • Neurosurgical curette, single-use

DuoFLEX® Coil Suite - 00857371006380

The 24cm Right Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1520G-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging.
M R Instruments, Inc.
FC1520G-8R
In Commercial Distribution

  • 00857371006380 ()
40-00297-002

  • MRI system coil, radio-frequency

DuoFLEX® Coil Suite - 00857371006373

The 24cm Left Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1520G-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging.
M R Instruments, Inc.
FC1520G-8R
In Commercial Distribution

  • 00857371006373 ()
40-00297-001

  • MRI system coil, radio-frequency
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