Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- Sinskey Nucleus Hydrodissector EUDAMEDFDA UDI
- Model / Reference
- SC-5345 EUDAMEDFDA UDI
- Description
- Sinskey Nucleus Hydrodissector FDA UDI
Identifiers
- Catalog Number
- SC-5345 FDA UDI
- Primary DI / UDI-DI
- 00810799038913 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799038913 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 I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
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
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Stephens Instruments by Krishna Imports Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Krishna Imports Inc
Sources (2)
- FDA UDI 7b53d7ec-3146-4ac5-b1be-c46e0e6e74b7 36 fields · synced Jun 18, 2026
- EUDAMED 8f99a528-e970-418a-a1d1-f00287aa9001 61 fields · synced Jun 18, 2026