Identity
- Trade Name
- Hydra FDA UDI
- Generic Name
- Surgical irrigation tubing set, reusable FDA UDI
- Device Name
- Irrigation Tubing System FDA UDI
- Model / Reference
- SIT-576 FDA UDI
- Description
- Irrigation Tubing System FDA UDI
Identifiers
- Catalog Number
- SIT-576 FDA UDI
- Primary DI / UDI-DI
- 00840253108432 FDA UDI
- FDA Product Code
- FEQ FDA UDI
- GMDN Term
- Surgical irrigation tubing set, reusable 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical irrigation tubing set, reusable
Hydra by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SOVEREIGN COMPACT — Johnson & Johnson Surgical Vision, Inc. · Class I
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- Irri clip ORIGO NANO/RAPIDO — Bien-Air Surgery SA · Class II
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
- Boston Scientific
Sources (1)
- FDA UDI f19a6b04-a9e2-4766-baa5-524e9d3fef67 34 fields · synced Jun 8, 2026