ComPel Isolation Gown

FDA UDI

Class I (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name: ComPel Isolation Gown FDA UDI
Generic Name: Isolation gown, reusable FDA UDI
Device Name: ComPel Isolation Gown, AAMI Level 2, 100% Polyester, Yellow, Tie Closures Neck and Waist, Raglan Sleeve with Poly Cuffs, Size Small FDA UDI
Model / Reference: 66103571 FDA UDI
Description: ComPel Isolation Gown, AAMI Level 2, 100% Polyester, Yellow, Tie Closures Neck and Waist, Raglan Sleeve with Poly Cuffs, Size Small FDA UDI

Identifiers

Primary DI / UDI-DI: 00634916822151 FDA UDI
FDA Product Code: OEA FDA UDI
GMDN Term: Isolation gown, reusable 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

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: Isolation gown, reusable

ComPel Isolation Gown by Standard Textile Co., 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: Standard Textile Co., Inc.

Sources (1)

FDA UDI 9c93aa45-6666-4f8e-854a-7ae013344709 34 fields · synced May 30, 2026