Identity
- Trade Name
- Irri clip ORIGO NANO/RAPIDO FDA UDI
- Generic Name
- Surgical irrigation tubing set, reusable FDA UDI
- Model / Reference
- 1306918 FDA UDI
Identifiers
- Catalog Number
- 1306918-010 FDA UDI
- Primary DI / UDI-DI
- 17630055504446 FDA UDI
- FDA Product Code
- HBC FDA UDIHBE FDA UDINLY FDA UDIERL FDA UDIEQJ FDA UDI
- GMDN Term
- Surgical irrigation tubing set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4360 FDA UDI882.4310 FDA UDI874.4140 FDA UDI874.4250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical irrigation tubing set, reusable
Irri clip ORIGO NANO/RAPIDO by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Hydra — Boston Scientific · Class II
- Shaver System — Stryker Corp. · Class I
- SOVEREIGN COMPACT — Johnson & Johnson Surgical Vision, Inc. · Class I
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
- Bien-Air Surgery SA
Sources (1)
- FDA UDI ca426d7b-5a9e-447b-b039-8a007d854d1c 33 fields · synced May 30, 2026