Lac-Mac

FDA UDI

Class II (US FDA UDI)

by Lac Mac, Ltd.

Identity

Trade Name: Lac-Mac FDA UDI
Generic Name: Sterilization packaging, reusable FDA UDI
Device Name: Wrap, 81 X 60, Level 2, single ply FDA UDI
Model / Reference: 084B-ON FDA UDI
Description: Wrap, 81 X 60, Level 2, single ply FDA UDI

Identifiers

Catalog Number: 084B-ON FDA UDI
Primary DI / UDI-DI: 00627755840332 FDA UDI
510(k) Number: K102864 FDA UDI
FDA Product Code: FRG FDA UDI
GMDN Term: Sterilization packaging, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6850 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 — 60 Inch FDA UDI
Length — 81 Inch FDA UDI

Category: Sterilization packaging, reusable

Lac-Mac by Lac Mac, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sterilization packaging, reusable.

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Encompass — Encompass Group, L.L.C. · Class II
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Medline — MEDLINE INDUSTRIES, INC. · Class II
Brasseler USA — Peter Brasseler Holdings, LLC · Class II
Brasseler USA — Peter Brasseler Holdings, LLC · Class II
E-Z Jett Cassette — ZIRC DENTAL PRODUCTS, INC. · Class I
Brasseler USA — Peter Brasseler Holdings, LLC · Class II

Cleared under the same submission

K102864 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 44cc1d87-2b51-448d-b014-1123cd5c8f43 37 fields · synced Jun 6, 2026