LID NAV2028K LG2NAV TAP MODULE LID
NA - NAV2028K
Device Description
A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
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: 00643169545892
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