Identity
- Trade Name
- IRRAflow® 1.5 Catheter FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, short-term FDA UDI
- Model / Reference
- ICGS 010 FDA UDI
Identifiers
- Catalog Number
- ICGS 010 FDA UDI
- Primary DI / UDI-DI
- 00868643000425 FDA UDI
- 510(k) Number
- K171880 FDA UDI
- FDA Product Code
- GWM FDA UDIJXG FDA UDI
- GMDN Term
- Intracerebral infusion/drainage catheter, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 FDA UDI882.5550 FDA UDI
- Commercial Distribution
- Not 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
IRRAflow® 1.5 Catheter by Irras USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K171880 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 84263d6f-d17c-4359-8881-3de4e861b197 37 fields · synced May 30, 2026