Identity
- Trade Name
- Duckworth & Kent FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- I/A Tip EUDAMEDFDA UDI
- Model / Reference
- 8-731-4 EUDAMEDFDA UDI
- Description
- I/A Tip FDA UDI
Identifiers
- Catalog Number
- 8-731-4 FDA UDI
- Primary DI / UDI-DI
- 05055313812586 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055313812586 EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- L1713 OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
I/A Tip by Duckworth & Kent Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05055313812586 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Duckworth & Kent Ltd.
- EUDAMED SRN
- GB-MF-000002176
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7266246f-ea74-4014-9ca5-5a0be7da4e78 61 fields · synced Jul 27, 2026
- FDA UDI 72c2ecc8-5d61-4872-99e7-9195ff14dac6 36 fields · synced May 30, 2026