Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Eyelid speculum, reusable FDA UDI
- Device Name
- Kratz Wing Speculum, w/o Bar, Child EUDAMEDKratz Wing Speculum, Without Bar, Child FDA UDI
- Model / Reference
- S1-1017 EUDAMEDFDA UDI
- Description
- Kratz Wing Speculum, Without Bar, Child FDA UDI
Identifiers
- Catalog Number
- S1-1017 FDA UDI
- Primary DI / UDI-DI
- 00810799030634 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799030634 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
Similar devices
Also classified as Eyelid speculum, reusable.
- Sklar® — Sklar Corporation · Class I
- Ophthalmic Speculum — AURORA SURGICAL, LLC · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- COOK EYE SPECULUM — SONTEC INSTRUMENTS, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Krishna Imports Inc
Sources (2)
- FDA UDI eecbb1c0-7897-45a3-8084-77843c3f3b43 36 fields · synced Jul 26, 2026
- EUDAMED 0022a5fc-3766-40a8-83ac-35ccd44c780f 61 fields · synced Jul 26, 2026