FDA UDI
In Commercial Distribution
🇺🇸 United States
IRRAflow Cranial Access Bolt
DI: 00850013266272
·
Model: ICB 010
·
Irras USA, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- IRRAflow Cranial Access Bolt
- Primary DI
- 00850013266272
- Version / Model
- ICB 010
- Company Name
- Irras USA, Inc.
- Labeler DUNS
- 056999617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-24
- Public Version
- 1
- Public Version Date
- 2025-08-01
- Public Version Status
- New
- Public Device Record Key
- 2ffe00c4-3cd0-44cf-b143-e3448af518ca
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | 882.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45552 | Patient monitoring system module, intracranial pressure | A small unit dedicated to the detection, measurement, and recording of intracranial pressure (ICP). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the parameter/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850013266279 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 00850013266272 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083378 | 000 |