IRRAflow Cranial Access Bolt

GUDID 10850013266279

The IRRAflow Cranial Access Bolt is a single use, single-lumen bolt intended for use with the IRRAflow Dual Lumen Catheter to secure the catheter to the patient's skull, sealing it to prevent unintended fluid entry or exit from the cranium. The Bolt comes pre-assembled with a Bolt Cap for securing the catheter, and a Dura Opener is included to facilitate catheter insertion by piercing the dura.

Irras USA, Inc.

Patient monitoring system module, intracranial pressure

• Primary Device ID: 10850013266279
• NIH Device Record Key: 2ffe00c4-3cd0-44cf-b143-e3448af518ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRRAflow Cranial Access Bolt
• Version Model Number: ICB 010
• Company DUNS: 056999617
• Company Name: Irras USA, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013266272 [Primary]
GS1	10850013266279 [Package]; Contains: 00850013266272; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083378

FDA Product Code

• GWM: Device, Monitoring, Intracranial Pressure

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: 2025-08-01
• Device Publish Date: 2025-07-24

Devices Manufactured by Irras USA, Inc.

• 10850013266279 - IRRAflow Cranial Access Bolt: 2025-08-01The IRRAflow Cranial Access Bolt is a single use, single-lumen bolt intended for use with the IRRAflow Dual Lumen Catheter to secure the catheter to the patient's skull, sealing it to prevent unintended fluid entry or exit from the cranium. The Bolt comes pre-assembled with a Bolt Cap for securing the catheter, and a Dura Opener is included to facilitate catheter insertion by piercing the dura.
• 10850013266279 - IRRAflow Cranial Access Bolt: 2025-08-01 The IRRAflow Cranial Access Bolt is a single use, single-lumen bolt intended for use with the IRRAflow Dual Lumen Catheter to se
• 00850013266258 - IRRAflow Catheter 2.0+: 2025-05-15 IRRAflow Catheter 2.0+ intended for use with the IRRAflow Active Fluid Exchange System
• 10868643000460 - IRRAflow Laser Leveler Package: 2024-06-18