Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- Gills Irrigating Cannula, 5, 7, 8, 10 mm, 25Ga, Angled EUDAMEDGills Irrigating Cannula, 8mm, 25ga, Angled FDA UDI
- Model / Reference
- SC-1065 EUDAMEDFDA UDI
- Description
- Gills Irrigating Cannula, 8mm, 25ga, Angled FDA UDI
Identifiers
- Catalog Number
- SC-1065 FDA UDI
- Primary DI / UDI-DI
- 00810799038111 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799038111 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 1bbc10c3-009b-4b77-b910-26d9adb4ec3e 36 fields · synced Jun 19, 2026
- EUDAMED 89d7b901-5d0e-4939-a9a4-b9f2608d3a30 61 fields · synced Jun 19, 2026