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: Head Drape, 70x102, Level 4, BARRIER 43x55 FDA UDI
Model / Reference: 091XQ FDA UDI
Description: Head Drape, 70x102, Level 4, BARRIER 43x55 FDA UDI

Identifiers

Catalog Number: 091XQ FDA UDI
Primary DI / UDI-DI: 00627755251060 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 — 70 Inch FDA UDI
Height — 102 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

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Manufacturer

Manufacturer: Lac Mac, Ltd.

Sources (1)

FDA UDI 3bb5522b-f022-4dd0-aec8-3b4a39f648d2 37 fields · synced May 30, 2026