Regard™

FDA UDI

Class I (US FDA UDI)

by Resource Optimization & Innovation, L.l.c.

Identity

Trade Name: Regard™ FDA UDI
Generic Name: Shoe cover FDA UDI
Device Name: SHOE COVER, TRAD, SKID RESISTANT, FLUID RESISTANT, SPUNBOUND, DISPOSABLE, NS, LF, BLUE, 2XL FDA UDI
Model / Reference: SHCVR2XL3-REG FDA UDI
Description: SHOE COVER, TRAD, SKID RESISTANT, FLUID RESISTANT, SPUNBOUND, DISPOSABLE, NS, LF, BLUE, 2XL FDA UDI

Identifiers

Catalog Number: SHCVR2XL3-REG FDA UDI
Primary DI / UDI-DI: 00326053119286 FDA UDI
FDA Product Code: FXP FDA UDI
GMDN Term: Shoe cover FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Shoe cover

Regard™ by Resource Optimization & Innovation, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Resource Optimization & Innovation, L.l.c.

Sources (1)

FDA UDI ee150a04-97da-4139-bd7e-2fa1a905de20 34 fields · synced May 31, 2026