SOFT SHIELD® Collagen Shields

FDA UDI

Class I (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name: SOFT SHIELD® Collagen Shields FDA UDI
Generic Name: Epithelial-resurfacing corneal shield FDA UDI
Device Name: SOFT SHIELD® Collagen Shield, 12 Hours (CE) FDA UDI
Model / Reference: 7012 FDA UDI
Description: SOFT SHIELD® Collagen Shield, 12 Hours (CE) FDA UDI

Identifiers

Primary DI / UDI-DI: 00845819005705 FDA UDI
FDA Product Code: MOE FDA UDI
GMDN Term: Epithelial-resurfacing corneal shield 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Epithelial-resurfacing corneal shield

A mechanical eye shield made of an animal-derived biodegradable material (e.g., collagen) intended to be placed on the eye to protect the cornea and permit clinical observation and partial patient vision during postsurgical epithelial resurfacing of the cornea. This is a single-use device.

Similar devices

Also classified as Epithelial-resurfacing corneal shield.

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CORNEAL SHIELD — Cynosure, LLC · Class I
SUCTION HANDLE FOR CORNEAL SHIELDS — Cynosure, LLC · Class I
CORNEAL SHIELD — Cynosure, LLC · Class I
DeRoyal — DEROYAL INDUSTRIES, 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: OASIS Medical, Inc.

Sources (1)

FDA UDI edf6ac78-6ab0-4663-b5f2-77633741f7fc 34 fields · synced Jul 10, 2026