Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Ophthalmic knife, reusable FDA UDI
- Device Name
- Foreign Body Needle, Curved EUDAMEDFDA UDI
- Model / Reference
- S2-1130 EUDAMEDFDA UDI
- Description
- Foreign Body Needle, Curved FDA UDI
Identifiers
- Catalog Number
- S2-1130 FDA UDI
- Primary DI / UDI-DI
- 00810799031341 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799031341 EUDAMED
- FDA Product Code
- HXK FDA UDI
- EMDN Code
- L170402 KERATOMES AND BLADES, REUSABLE EUDAMED
- GMDN Term
- Ophthalmic knife, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic knife, 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
European Union Unknown
MDD
United States Pending data
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 f2141c56-8129-412f-84b7-4299b8fd0070 36 fields · synced Jul 21, 2026
- EUDAMED ff08c8c1-3c24-4b43-af49-03c1eb0ca04f 61 fields · synced Jul 21, 2026