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Standard Supreme Drape Sheet

FDA UDI

Class II (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name
Standard Supreme Drape Sheet FDA UDI
Generic Name
Patient surgical drape, reusable FDA UDI
Device Name
T180 Flat Sheet, 55% Cotton / 45% Polyester, Ceil (70x180) FDA UDI
Model / Reference
22940122 FDA UDI
Description
T180 Flat Sheet, 55% Cotton / 45% Polyester, Ceil (70x180) FDA UDI

Identifiers

Primary DI / UDI-DI
00634916465396 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Patient surgical drape, reusable

Standard Supreme Drape Sheet by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient surgical drape, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 5064f390-f2fd-4919-8bcf-6977ed53743c 34 fields · synced May 31, 2026