Standard Supreme Drape

FDA UDI

Class II (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name: Standard Supreme Drape FDA UDI
Generic Name: Patient surgical drape, reusable FDA UDI
Device Name: Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1 Ply Body, 2 Ply Front Pocket Panel, Misty, 21 3/4 x 44 FDA UDI
Model / Reference: 95301682 FDA UDI
Description: Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1 Ply Body, 2 Ply Front Pocket Panel, Misty, 21 3/4 x 44 FDA UDI

Identifiers

Catalog Number: 95301682 FDA UDI
Primary DI / UDI-DI: 00634916000016 FDA UDI
FDA Product Code: PUI FDA UDI
GMDN Term: Patient surgical drape, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Patient surgical drape, reusable

Standard Supreme Drape by Standard Textile Co., Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Standard Textile Co., Inc.

Sources (1)

FDA UDI 99134396-1838-4c93-9906-7267e0480129 35 fields · synced May 30, 2026