COMPASS Stereotactic System PION-20

GUDID 00860009258112

COMPASS Stereotactic Frame System

Compass International

Neurological stereotactic surgery system

• Primary Device ID: 00860009258112
• NIH Device Record Key: 6f52bf52-181c-40b4-9c84-1da0f692259d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPASS Stereotactic System
• Version Model Number: PION-20
• Catalog Number: PION-20
• Company DUNS: 809466410
• Company Name: Compass International
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009258112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871046

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[00860009258112]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00860009258112]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00860009258112]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00860009258112]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00860009258112]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00860009258112]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00860009258112]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00860009258112]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-06
• Device Publish Date: 2026-01-29

Devices Manufactured by Compass International

• 00860009258105 - COMPASS CYGNUS-PFS IGS System: 2026-02-06 COMPASS CYGNUS-PFS Image Guide System
• 00860009258112 - COMPASS Stereotactic System: 2026-02-06COMPASS Stereotactic Frame System
• 00860009258112 - COMPASS Stereotactic System: 2026-02-06 COMPASS Stereotactic Frame System
• B169SST100 - Compass International: 2020-04-20 Sundt Stereotaxic Suction Tip
• B169RU1500 - Compass International: 2019-05-07 150 MM Ruler
• B169RU3000 - Compass International: 2019-05-07 300 MM Ruler
• B169AW050100 - Compass: 2018-10-05 Allen Wrench w/handle .050
• B16963MRL0 - Compass International: 2018-03-29 Micrometer for measuring Carbon Fiber Pins on Head Frame
• B169CW200 - Compass International: 2018-03-29 Collet Wrench