Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Ocular hook/spatula/manipulator, reusable FDA UDI
- Device Name
- Scleral Hook, Twist Fixation, 0.5 mm Right EUDAMEDScleral Hook, Twist Fixation, 0.5mm Right FDA UDI
- Model / Reference
- S4-1290 EUDAMEDFDA UDI
- Description
- Scleral Hook, Twist Fixation, 0.5mm Right FDA UDI
Identifiers
- Catalog Number
- S4-1290 FDA UDI
- Primary DI / UDI-DI
- 00810799032317 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799032317 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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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 174668b0-62e5-48bf-ba6b-f96f9bb5d45d 36 fields · synced Jul 20, 2026
- EUDAMED f4415d2e-3049-418c-a35f-1f16300575e4 61 fields · synced Jul 20, 2026