MediChoice

FDA UDI

Class I (US FDA UDI)

by Owens & Minor Distribution, Inc.

Identity

Trade Name: MediChoice FDA UDI
Generic Name: Shoe cover FDA UDI
Device Name: Cover Shoe Fluid-Resistant Non-Skid Tread Durable Elastic Band Upper Extra-Large Spun Bond Polypropylene Blue Not Made With Natural Rubber Latex MediChoice FDA UDI
Model / Reference: 77727 FDA UDI
Description: Cover Shoe Fluid-Resistant Non-Skid Tread Durable Elastic Band Upper Extra-Large Spun Bond Polypropylene Blue Not Made With Natural Rubber Latex MediChoice FDA UDI

Identifiers

Primary DI / UDI-DI: 30885632105313 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

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

MediChoice by Owens & Minor Distribution, Inc. — 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: Owens & Minor Distribution, Inc.

Sources (1)

FDA UDI da48a614-1de2-4564-a388-28cd7752ba58 33 fields · synced May 30, 2026