Precept®

FDA UDI

Class I (US FDA UDI)

by Precept Medical Products, Inc.

Identity

Trade Name: Precept® FDA UDI
Generic Name: Shoe cover, conductive, non-sterile FDA UDI
Device Name: Cleanroom Shoe Covers with Embossed Poly Sole FDA UDI
Model / Reference: 35 60420L FDA UDI
Description: Cleanroom Shoe Covers with Embossed Poly Sole FDA UDI

Identifiers

Primary DI / UDI-DI: 20814707020933 FDA UDI
FDA Product Code: FXP FDA UDI
GMDN Term: Shoe cover, conductive, non-sterile 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

Yes

FDA UDI

Category: Shoe cover, conductive, non-sterile

Precept® by Precept Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Precept® — Precept Medical Products, Inc. · Class I
Precept® — Precept Medical Products, Inc. · Class I
Precept® — Precept Medical Products, Inc. · Class I
Precept® — Precept Medical Products, 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: Precept Medical Products, Inc.

Sources (1)

FDA UDI abb5b8d0-54fe-421a-9f41-4a514a95d5d2 34 fields · synced May 30, 2026