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Infant Wire Speculum, Blade Size 5mm Close
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref D10-5320Model D10-5000-9019
Identity
- Trade Name
- Infant Wire Speculum EUDAMEDFDA UDIInfant Wire Speculum, Blade Size 5mm Close FDA UDI
- Generic Name
- Eyelid speculum, reusable FDA UDI
- Device Name
- Ophthalmic Speculums EUDAMEDTO EXPOSE THE OCULAR SURFACE BY PERVENTING EYELIDS FROM CLOSING FDA UDI
- Model / Reference
- D10-5320 EUDAMEDFDA UDID10-5000-9019 EUDAMEDD10-5325 FDA UDI
- Description
- TO EXPOSE THE OCULAR SURFACE BY PERVENTING EYELIDS FROM CLOSING FDA UDI
Identifiers
- Catalog Number
- D10-5325 FDA UDID10-5320 FDA UDI
- Primary DI / UDI-DI
- +G006D10532001 EUDAMEDG006D1053250 FDA UDIG006D1053200 FDA UDI
- Basic UDI-DI
- ++G006OphthalSpeculumU8 EUDAMED
- FDA Product Code
- HNC FDA UDI
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMED
- GMDN Term
- Eyelid speculum, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Eyelid speculum, reusable
Infant Wire Speculum, Blade Size 5mm Close by Daud Jee Mfg. Co — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Eyelid speculum, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Daud Jee Mfg. Co
Sources (3)
- FDA UDI 9064bfa3-281d-4e79-96ff-19604e2dbb40 34 fields · synced Jul 22, 2026
- FDA UDI 25285599-e284-41d1-ba9c-cc59b1cee9d2 34 fields · synced May 30, 2026
- EUDAMED 4b0211bf-51ab-4b0f-b8cf-aee803896765 61 fields · synced Jul 22, 2026