IRRAflow® Drainage Collection System
FDA UDIEUDAMEDClass II (US FDA UDI)
by Irras USA
Identity
- Trade Name
- IRRAflow Drainage Collection System EUDAMEDIRRAflow® Drainage Collection System FDA UDI
- Generic Name
- Intracerebral sensor catheter, short-term FDA UDI
- Device Name
- IRRAflow Drainage Collection System EUDAMEDDCS 010 Drainage Collection System FDA UDI
- Model / Reference
- DCS 010 EUDAMEDFDA UDI
- Description
- DCS 010 Drainage Collection System FDA UDI
Identifiers
- Catalog Number
- DCS 010 FDA UDI
- Primary DI / UDI-DI
- 00868643000470 EUDAMEDFDA UDI
- Basic UDI-DI
- 086864300047CZ EUDAMED
- 510(k) Number
- K171880 FDA UDI
- FDA Product Code
- JXG FDA UDIGWM FDA UDI
- EMDN Code
- N01038099 INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Intracerebral sensor catheter, short-term FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5550 FDA UDI882.1620 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Intracranial pressure monitorIntracerebral sensor catheter, short-term
IRRAflow® Drainage Collection System by Irras USA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral sensor catheter, short-term.
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Cleared under the same submission
K171880 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Irras USA
Sources (2)
- FDA UDI ad59ad51-42f2-41c6-a19b-984370ab02ca 37 fields · synced Jun 19, 2026
- EUDAMED a60acaa9-06b2-4d1f-955c-91f8bdf14948 61 fields · synced Jun 19, 2026