Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Eyelid speculum, reusable FDA UDI
- Device Name
- Barraquer Wire Speculum, Child, Nasal, 12 mm EUDAMEDBarraquer Wire Speculum, Child, Temporal, 12mm FDA UDI
- Model / Reference
- S1-1011 EUDAMEDFDA UDI
- Description
- Barraquer Wire Speculum, Child, Temporal, 12mm FDA UDI
Identifiers
- Catalog Number
- S1-1011 FDA UDI
- Primary DI / UDI-DI
- 00810799030542 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799030542 EUDAMED
- FDA Product Code
- HNC FDA UDI
- EMDN Code
- L170102 OCULAR AND ENDOCULAR RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Eyelid speculum, 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: Eyelid speculum, 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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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 6d31c636-5912-4d51-a36c-0525048a60a6 36 fields · synced Jun 18, 2026
- EUDAMED c5670373-e100-4796-9b9d-cf475c298c40 61 fields · synced Jun 18, 2026