Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Ocular hook/spatula/manipulator, reusable FDA UDI
- Device Name
- Fenzl Lens Manipulating Hook, Angled EUDAMEDFDA UDI
- Model / Reference
- S4-1374 EUDAMEDFDA UDI
- Description
- Fenzl Lens Manipulating Hook, Angled FDA UDI
Identifiers
- Catalog Number
- S4-1374 FDA UDI
- Primary DI / UDI-DI
- 00810799032515 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799032515 EUDAMED
- FDA Product Code
- HNQ FDA UDI
- EMDN Code
- L1711 OPHTHALMOLOGY HOOKS, REUSABLE EUDAMED
- GMDN Term
- Ocular hook/spatula/manipulator, 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
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: Ocular hook/spatula/manipulator, 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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Also classified as Ocular hook/spatula/manipulator, reusable.
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- Surgical Direct — SURGICAL DIRECT, INC. · Class I
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 af619857-d7d6-4766-88ab-e32f25656fdc 36 fields · synced Jun 18, 2026
- EUDAMED 9f1e7f75-5a96-4efc-9f96-d1b364ba0b23 61 fields · synced Jun 18, 2026