NavSuite¿3 Cable for Camera Arm 15FT
NAVSUITE - 7700-009-101
Device Description
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OLO
Device Name: Orthopedic Stereotaxic Instrument
Device Class: 2
Physical State: Device consists of Camera, computer, various shaped tracking arrays, computer interface for commmunication between user and device.
Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: User loads Computer software pre-Op to plan surgery procedure, then registers the patient anatomy during surgery to allow software to track patient anatomy, implants, and surgical tools in real time/space.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Orthopedic joints and spinal procedures where tracking of instrumentation is desired.
Regulation Number: 882.4560
Third Party Flag: N
Medical Specialty: NE
Device IdentifiersDevice Id: 07613327114959
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A