Lac-Mac

FDA UDI

Class II (US FDA UDI)

by Lac Mac, Ltd.

Identity

Trade Name: Lac-Mac FDA UDI
Generic Name: Patient surgical drape, reusable FDA UDI
Device Name: Back Table Cover, 100 x 54, LEVEL 4, BARRIER 85.5X54 FDA UDI
Model / Reference: 025XNAB FDA UDI
Description: Back Table Cover, 100 x 54, LEVEL 4, BARRIER 85.5X54 FDA UDI

Identifiers

Catalog Number: 025XNAB FDA UDI
Primary DI / UDI-DI: 00627755250445 FDA UDI
510(k) Number: K031362 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 100 Inch FDA UDI
Width — 54 Inch FDA UDI

Category: Patient surgical drape, reusable

Lac-Mac by Lac Mac, Ltd. — 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
Medline — MEDLINE INDUSTRIES, INC. · Class II
Medline — MEDLINE INDUSTRIES, INC. · 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

Cleared under the same submission

K031362 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Lac Mac, Ltd.

Sources (1)

FDA UDI caae0f28-5f91-45b2-a2c2-95157511e9ad 37 fields · synced Jun 8, 2026