Identity
- Trade Name
- IRRAflow Cranial Access Bolt FDA UDI
- Generic Name
- Patient monitoring system module, intracranial pressure FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- ICB 010 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013266272 FDA UDI
- 510(k) Number
- K083378 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Patient monitoring system module, intracranial pressure FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Patient monitoring system module, intracranial pressure
IRRAflow Cranial Access Bolt by Irras USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083378 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Irras USA
Sources (1)
- FDA UDI 2ffe00c4-3cd0-44cf-b143-e3448af518ca 34 fields · synced May 30, 2026