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Jaffe Wire Lid Retractor Pair, Lg
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref D10-8000Model D10-5000-9019
Identity
- Trade Name
- JAFFE WIRE LID RETRACTOR PAIR, LG 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
- D10-8000 EUDAMEDFDA UDID10-5000-9019 EUDAMED
- Description
- TO EXPOSE THE OCULAR SURFACE BY PERVENTING EYELIDS FROM CLOSING FDA UDI
Identifiers
- Catalog Number
- D10-8000 FDA UDI
- Primary DI / UDI-DI
- +G006D1080000% EUDAMEDG006D1080000 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
Jaffe Wire Lid Retractor Pair, Lg by Daud Jee Mfg. Co — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 59141c7e-3283-4ccc-8119-334629e161fd 34 fields · synced Jul 31, 2026
- EUDAMED a7db9efe-d106-457a-9833-63026b3924a0 61 fields · synced Jul 31, 2026