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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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L-Varlock - 00850011324110

The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
110
In Commercial Distribution

  • 00850011324110 ()

  • Height: 9 Millimeter
  • Width: 10 Millimeter
VAL-CA-10-09

  • Metallic spinal fusion cage, non-sterile

L-Varlock - 00850011324004

The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
004
In Commercial Distribution

  • 00850011324004 ()

  • Width: 13 Millimeter
  • Height: 8 Millimeter
VAL-CA-13-08

  • Metallic spinal fusion cage, non-sterile

ATLAS Power Isolator 220VAC - 00850011306994

An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patient leakage current to an acceptable level.
NEURALYNX, INC.
220VAC
In Commercial Distribution

  • 00850011306994 ()
31-0607-0009

  • Uninterruptible power supply system

ATLAS Power Isolator 110VAC - 00850011306987

An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patient leakage current to an acceptable level.
NEURALYNX, INC.
110VAC
In Commercial Distribution

  • 00850011306987 ()
31-0607-0008

  • Uninterruptible power supply system

Zipshield 8m - 00850011306970

This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.
NEURALYNX, INC.
8m
In Commercial Distribution

  • 00850011306970 ()
31-0604-0129

  • Facility radio-frequency shielding material

Zipshield 5m - 00850011306963

This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.
NEURALYNX, INC.
5m
In Commercial Distribution

  • 00850011306963 ()
31-0604-0128

  • Facility radio-frequency shielding material

ATLAS Parallel TTL Cable - 00850011306956

The Parallel TTL Cable is a ribbon cable that connects 25 pin computer parallel port to the digital I/O port on the ATLAS System, for the purpose of sending and receiving signals.
NEURALYNX, INC.
ATLAS Parallel TTL Cable
In Commercial Distribution

  • 00850011306956 ()
31-0602-0024

  • Electrical-only medical device connection cable, reusable

ATLAS Workstation - 00850011306949

The ATLAS Workstation is a computer that runs the Data Acquisition Software.
NEURALYNX, INC.
ATLAS Workstation
In Commercial Distribution

  • 00850011306949 ()
31-0004-0000

  • Electroencephalographic monitoring system

ATLAS Workstation Monitor - 00850011306932

The ATLAS Workstation Monitor connects to the ATLAS Workstation (31-0004-0000).
NEURALYNX, INC.
ATLAS Workstation Monitor
In Commercial Distribution

  • 00850011306932 ()
31-0000-0002

  • Electroencephalographic monitoring system

ATLAS Headbox Interface Cable - High Density - 00850011306925

Cable to connect 100-pin Hirose connector to Natus connector.
NEURALYNX, INC.
High Density
In Commercial Distribution

  • 00850011306925 ()
31-0204-0005

  • Electrical-only medical device connection cable, reusable
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