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Ginsberg Eye Speculum
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref D10-5679Model D10-5000-9019
Identity
- Trade Name
- Ginsberg Eye Speculum EUDAMEDFDA 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
- D10-5679 EUDAMEDFDA UDID10-5000-9019 EUDAMED
- Description
- TO EXPOSE THE OCULAR SURFACE BY PERVENTING EYELIDS FROM CLOSING FDA UDI
Identifiers
- Catalog Number
- D10-5679 FDA UDI
- Primary DI / UDI-DI
- +G006D1056790I EUDAMEDG006D1056790 FDA UDI
- Basic UDI-DI
- ++G006OphthalSpeculumU8 EUDAMED
- FDA Product Code
- HNC FDA UDI
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, 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
Ginsberg Eye Speculum 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 (2)
- FDA UDI c622474f-fd3c-46c4-ae64-8b62e7c8fa1a 34 fields · synced Jul 16, 2026
- EUDAMED a9f61cb2-49f9-4e3b-9147-2efddcdb16d9 61 fields · synced Jul 16, 2026