Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Lacrimal dilator, reusable FDA UDI
- Device Name
- Simpson Lacrimal Dilator, Size #1, Medium EUDAMEDFDA UDI
- Model / Reference
- S8-1025 EUDAMEDFDA UDI
- Description
- Simpson Lacrimal Dilator, Size #1, Medium FDA UDI
Identifiers
- Catalog Number
- S8-1025 FDA UDI
- Primary DI / UDI-DI
- 00810799037206 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799037206 EUDAMED
- FDA Product Code
- HNW FDA UDI
- EMDN Code
- Q020701 LACRIMAL DUCT DILATORS EUDAMED
- GMDN Term
- Lacrimal dilator, 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: Lacrimal dilator, 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 94c36ae7-2755-4760-936d-640bffa34c0a 36 fields · synced Jul 9, 2026
- EUDAMED c8642877-82cc-4408-92a1-53937a60863a 61 fields · synced Jul 9, 2026