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Sauer Lid Speculum, For Premature Infants
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref D10-5350Model D10-5000-9019Ref D10-5300Ref D10-5302
Identity
- Trade Name
- SAUER LID SPECULUM, FOR PREMATURE INFANTS EUDAMEDFDA UDIINFANT LID SPECULUM. EUDAMEDFDA UDISAUER LID SPECULUM, FOR INFANTS EUDAMED
- 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
- D10-5302 EUDAMEDFDA UDID10-5350 EUDAMEDFDA UDID10-5000-9019 EUDAMEDD10-5300 EUDAMED
- Description
- TO EXPOSE THE OCULAR SURFACE BY PERVENTING EYELIDS FROM CLOSING FDA UDI
Identifiers
- Catalog Number
- D10-5302 FDA UDID10-5350 FDA UDI
- Primary DI / UDI-DI
- +G006D10535004 EUDAMED+G006D1053000% EUDAMED+G006D10530201 EUDAMEDG006D1053020 FDA UDIG006D1053500 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
Sauer Lid Speculum, For Premature Infants 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 (5)
- FDA UDI 632feccb-82a7-4aae-b8d1-b8161c6a349a 34 fields · synced Aug 2, 2026
- FDA UDI 8a7a7b51-1794-409b-b1bb-268d75e975fb 34 fields · synced May 30, 2026
- EUDAMED 357cfd59-2ea5-4415-a055-1e262459aea2 61 fields · synced Jul 23, 2026
- EUDAMED 10177546-99f1-4e9c-bf1a-fdb5d330f562 61 fields · synced Jul 24, 2026
- EUDAMED 4e19cfec-ab1c-43ba-b9cc-28ca30e56e67 61 fields · synced Aug 2, 2026