Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Medline FDA UDI
Generic Name: Patient surgical drape, reusable FDA UDI
Device Name: SHEET,EENT,SPLIT,75"X120",RESISTAT FDA UDI
Model / Reference: MDT013651 FDA UDI
Description: SHEET,EENT,SPLIT,75"X120",RESISTAT FDA UDI

Identifiers

Catalog Number: MDT013651 FDA UDI
Primary DI / UDI-DI: 10888277114494 FDA UDI
FDA Product Code: KKX 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

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

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient surgical drape, reusable.

ComPel Surgical Drape — STANDARD TEXTILE CO., INC. · Class II
Lac-Mac — Lac Mac, Ltd. · Class II
ComPel Surgical Drape — STANDARD TEXTILE CO., INC. · Class II
Encompass — Encompass Group, L.L.C. · Class II
Fenestrated Heart Drape — STANDARD TEXTILE CO., INC. · Class II
ComPel Surgical Drape — STANDARD TEXTILE CO., INC. · Class II
NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
Lac-Mac — Lac Mac, Ltd. · Class II

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: Medline Industries, Inc.

Sources (1)

FDA UDI c25d97a3-d246-4b7e-86d1-01ae088dbeab 35 fields · synced May 31, 2026