Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Eyelid clamp, reusable FDA UDI
- Device Name
- Ayer Chalazion Forceps, Without Screw EUDAMEDFDA UDI
- Model / Reference
- S5-1005 EUDAMEDFDA UDI
- Description
- Ayer Chalazion Forceps, Without Screw FDA UDI
Identifiers
- Catalog Number
- S5-1005 FDA UDI
- Primary DI / UDI-DI
- 00810799033253 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799033253 EUDAMED
- FDA Product Code
- HNR FDA UDI
- EMDN Code
- L170102 OCULAR AND ENDOCULAR RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Eyelid clamp, 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 clamp, 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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Also classified as Eyelid clamp, reusable.
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- Oph.Forceps — Katena Products, Inc. · Class I
- American Medicals — AMERICAN MEDICALS · 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 |
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Manufacturer
- Manufacturer
- Krishna Imports Inc
Sources (2)
- FDA UDI 337455c1-a09a-4be0-a372-45d09cb64f5f 36 fields · synced Jun 18, 2026
- EUDAMED c0db7902-fa1d-4391-9f64-82a8fb679dc7 61 fields · synced Jun 18, 2026