Identity
- Trade Name
- IRRI-FLO I FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- IRRI-FLO I Irrigation Delivery System FDA UDI
- Model / Reference
- 5920000 FDA UDI
- Description
- IRRI-FLO I Irrigation Delivery System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925009523 FDA UDI
- 510(k) Number
- K891339 FDA UDI
- FDA Product Code
- OCX FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Category: Surgical irrigation tubing set, single-use
Irri-Flo I by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation tubing set, single-use.
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- Arthrex® — Arthrex, Inc. · Class I
- CODMAN® — Integra LifeSciences Switzerland Sàrl · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Endo-Flo — Davol Inc. · Class II
Cleared under the same submission
K891339 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI cc765549-e14b-4f16-b841-652c8fdd6f8b 34 fields · synced May 30, 2026