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Sign in to claim this brandIRRIMAX CORPORATION
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1665 Lakes Parkway, Lawrenceville, GA, 30043
- Website
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3005706359
- DUNS Number
- —
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Irrimax | Max-101 | FDA UDI | Class I | Unknown |
| Irrisept Rapid Packaging - 150 ml non sterile-Rapid Packaging | ISEPT-150RP-USA | FDA UDI | Class II | Active |
| Irrisept | Irrisept-403 | FDA UDI | Class II | Unknown |
| Irrisept Antimicrobial Wound Lavage | ISEPT-150N-USA | FDA UDI | Class II | Active |
| Irrisept Wound Solution Kit | ISEPT-WS-USA | FDA UDI | U | Active |
| Irrisept | CT-901 | FDA UDI | Class II | Unknown |
| Irrisept | ISEPT-450-STU | FDA UDI | Class II | Unknown |
| Irrisept Antimicrobial Wound Lavage | ISEPT-500-INT | FDA UDI | Class II | Active |
| Irrisept | ISEPT-500-CAN | FDA UDI | Class II | Unknown |
| Irrisept Antimicrobial Wound Lavage | ISEPT-450-USA | FDA UDI | Class II | Active |
| Irrisept Antimicrobial Wound Lavage | ISEPT-150RP-INT | FDA UDI | Class II | Active |
| Irrisept | APP-001 | FDA UDI | Class II | Unknown |
| Irrisept Antimicrobial Wound Lavage - 150 ml sterile | ISEPT-150-INT | FDA UDI | Class II | Active |
| Irrisept Accessory Kit | ISEPT-AK-USA | FDA UDI | U | Active |
| Irrisept Antimicrobial Wound Lavage | K222804 | FDA 510(k) | Class II | Active |
| Irrisept Antimicrobial Wound Lavage | K240552 | FDA 510(k) | U | Active |
| Irrisept Wound Cleansing System | K080779 | FDA 510(k) | Class II | Active |
| Irrisept Antimicrobial Wound Lavage | K210536 | FDA 510(k)FDA UDI | Class II | Active |
| Irrisept Wound Debridement and Cleansing System | K202222 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 16, 2019 | Z-0191-2020 | — | terminated | Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. |