SOLOPASS 2.0 Patient Interface Device PID50-5002

GUDID 00860012211906

A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter guide.

inTRAvent Medical Partners, L.P.

Neurological stereotactic surgery system

• Primary Device ID: 00860012211906
• NIH Device Record Key: a4c06c31-e8a5-4895-8576-e0944e373f41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLOPASS 2.0 Patient Interface Device
• Version Model Number: 1
• Catalog Number: PID50-5002
• Company DUNS: 052770186
• Company Name: inTRAvent Medical Partners, L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00860012211906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251317

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

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: 2025-12-19A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter guide.
• 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: 2025-12-19 Workstation/ Display with software that uses 2D intra-op ultrasound data to provide simultaneous location data for 3D anatomy.