Identity
- Trade Name
- Sharn Inc FDA UDI
- Generic Name
- Eye patch FDA UDI
- Device Name
- EyeGuardian Sensitive FDA UDI
- Model / Reference
- 42593 FDA UDI
- Description
- EyeGuardian Sensitive FDA UDI
Identifiers
- Catalog Number
- 42593 FDA UDI
- Primary DI / UDI-DI
- 00811571030842 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Eye patch FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Eye patch
Sharn Inc by Clear Image Devices Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye patch.
- COVERCLUDE OCCLUSION EYE PATCHES — FRESNEL PRISM & LENS CO. · Class I
- VISION SCREENING PATCH — FRESNEL PRISM & LENS CO. · Class I
- Sharn Inc — Sharn Anesthesia · Class I
- MYI OCCLUSION EYE PATCHES — FRESNEL PRISM & LENS CO. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Sharn Inc — Sharn Anesthesia · Class I
- iPRO — FANNIN (UK) LIMITED · Class I
- Optego — Optego Vision USA, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clear Image Devices Llc
Sources (1)
- FDA UDI a8ada8f0-95c2-4542-9873-3ff69fd23ab0 34 fields · synced May 30, 2026