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IRRAflow® 2.0 Catheter

FDA UDI

Class II (US FDA UDI)

by Irras USA

Identity

Trade Name
IRRAflow® 2.0 Catheter FDA UDI
Generic Name
Intracerebral infusion/drainage catheter, short-term FDA UDI
Model / Reference
ICGS 020 FDA UDI

Identifiers

Catalog Number
ICGS 020 FDA UDI
Primary DI / UDI-DI
00868643000432 FDA UDI
510(k) Number
K171880 FDA UDI
FDA Product Code
GWM FDA UDI
JXG FDA UDI
GMDN Term
Intracerebral infusion/drainage catheter, short-term FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1620 FDA UDI
882.5550 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
MRI Safety
MR Conditional FDA UDI

Category: Intracerebral infusion/drainage catheter, short-term

IRRAflow® 2.0 Catheter by Irras USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracerebral infusion/drainage catheter, short-term.

Cleared under the same submission

K171880 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Irras USA

Sources (1)

  • FDA UDI a034dc59-94a2-43aa-84e7-22b0c1e784fe 36 fields · synced May 30, 2026