SOLOPASS 2.0 Workstation CRT30-0000

GUDID 00860012211920

Workstation/ Display with software that uses 2D intra-op ultrasound data to provide simultaneous location data for 3D anatomy.

inTRAvent Medical Partners, L.P.

Neurological stereotactic surgery system

• Primary Device ID: 00860012211920
• NIH Device Record Key: 850f76bc-af23-4b51-81a6-d87ce0bbaeb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLOPASS 2.0 Workstation
• Version Model Number: 1
• Catalog Number: CRT30-0000
• Company DUNS: 052770186
• Company Name: inTRAvent Medical Partners, L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com
• Phone: 999-999-9999
• Email: quality@intraventmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012211920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251317

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-19
• Device Publish Date: 2025-12-11

Devices Manufactured by inTRAvent Medical Partners, L.P.

• 00860012211906 - SOLOPASS 2.0 Patient Interface Device: 2025-12-19 A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Cat
• 00860012211913 - SOLOPASS 2.0 Ultrasound Cable Assembly: 2025-12-19 Ultrasound Cable Assembly includes the probe tip, handle assembly and a connector.
• 00860012211920 - SOLOPASS 2.0 Workstation: 2025-12-19Workstation/ Display with software that uses 2D intra-op ultrasound data to provide simultaneous location data for 3D anatomy.
• 00860012211920 - SOLOPASS 2.0 Workstation: 2025-12-19 Workstation/ Display with software that uses 2D intra-op ultrasound data to provide simultaneous location data for 3D anatomy.