Identity
- Trade Name
- Irri clip S120/80K/NANO/RAPIDO FDA UDI
- Generic Name
- Surgical irrigation tubing set, reusable FDA UDI
- Model / Reference
- 1302844 FDA UDI
Identifiers
- Catalog Number
- 1302844-010 FDA UDI
- Primary DI / UDI-DI
- 17630055504392 FDA UDI
- FDA Product Code
- GBX FDA UDI
- GMDN Term
- Surgical irrigation tubing set, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
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 S120/80K/NANO/RAPIDO by Bien-Air Surgery SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation tubing set, reusable.
- Shaver System — Stryker Corp. · Class II
- COMPACT INTUITIV — Johnson & Johnson Surgical Vision, Inc. · Class II
- Shaver System — Stryker Corp. · Class I
- Irrigation line, Kavo — Omnia Spa · Class I
- Hydra — Boston Scientific · Class II
- 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bien-Air Surgery SA
Sources (1)
- FDA UDI 994a2919-1cf6-40b4-977f-b3a7031583ab 33 fields · synced May 30, 2026