Fenestrated Heart Drape

FDA UDI

Class II (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name: Fenestrated Heart Drape FDA UDI
Generic Name: Patient surgical drape, reusable FDA UDI
Device Name: Fenestrated Heart Drape, 1 Ply White T180 Drape, 1 Ply 15" x 15" Ceil Barrier Supreme Reinforcement Pad, 7 1/2" Square Fenestration, Concealed Hems Around Reinforcement Pad FDA UDI
Model / Reference: 96617530 FDA UDI
Description: Fenestrated Heart Drape, 1 Ply White T180 Drape, 1 Ply 15" x 15" Ceil Barrier Supreme Reinforcement Pad, 7 1/2" Square Fenestration, Concealed Hems Around Reinforcement Pad FDA UDI

Identifiers

Catalog Number: 96617530 FDA UDI
Primary DI / UDI-DI: 00634916683059 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

Fenestrated Heart 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 8ddd6752-228e-41a7-9bf9-45fb04480e9a 35 fields · synced May 30, 2026