Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Lacrimal dilator, reusable FDA UDI
- Device Name
- Wilder Lacrimal Dilator, Heavy Taper EUDAMEDFDA UDI
- Model / Reference
- S8-1035 EUDAMEDFDA UDI
- Description
- Wilder Lacrimal Dilator, Heavy Taper FDA UDI
Identifiers
- Catalog Number
- S8-1035 FDA UDI
- Primary DI / UDI-DI
- 00810799037220 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799037220 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 9da99380-3cbe-4dd5-bfae-60c85a94a985 36 fields · synced Jun 19, 2026
- EUDAMED 8c3cdaaa-7c86-4682-808d-ce0199f0e699 61 fields · synced Jun 19, 2026