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Clear Eye Shield - Non-sterile

FDA UDI

Class I (US FDA UDI)

by Hurricane Medical

Identity

Trade Name
Clear Eye Shield - Non-sterile FDA UDI
Generic Name
Eye mask FDA UDI
Device Name
Protects the eye during or after surgery, or after trauma. Universal for left or right eye. FDA UDI
Model / Reference
9401 FDA UDI
Description
Protects the eye during or after surgery, or after trauma. Universal for left or right eye. FDA UDI

Identifiers

Catalog Number
9401 FDA UDI
Primary DI / UDI-DI
00813465012156 FDA UDI
FDA Product Code
HOY FDA UDI
GMDN Term
Eye mask 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

Yes

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

No

FDA UDI

Category: Eye mask

Clear Eye Shield - Non-sterile by Hurricane Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eye mask.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hurricane Medical

Sources (1)

  • FDA UDI 04038497-960d-4c60-8e79-39c99715608d 34 fields · synced May 30, 2026