Unipack

FDA UDI

Class II (US FDA UDI)

by Dukal LLC

Identity

Trade Name: Unipack FDA UDI
Generic Name: Medical equipment/instrument drape, single-use FDA UDI
Device Name: Barrier Film 4" x 6" 1200 sheets/roll Clear FDA UDI
Model / Reference: UBC-8049 FDA UDI
Description: Barrier Film 4" x 6" 1200 sheets/roll Clear FDA UDI

Identifiers

Catalog Number: UBC-8049 FDA UDI
Primary DI / UDI-DI: 20665973031839 FDA UDI
510(k) Number: K183263 FDA UDI
FDA Product Code: PEM FDA UDI
GMDN Term: Medical equipment/instrument drape, single-use 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

Yes

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

Category: Medical equipment/instrument drape, single-use

Unipack by Dukal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment/instrument drape, single-use.

Plasdent — PLASDENT CORP. · Class II
Exact Medical Manufacturing, Inc. — Exact Medical Manufacturing · Class II
Proteger — DAS Medical International SRL · Class II
Machine Bag — Dynarex Corp. · Class I
TIDIShield — TIDI PRODUCTS, LLC · Class II
MICROTEK — Microtek Medical LLC · Class II
Plasdent — PLASDENT CORP. · Class II
Probe Cover — Advance Medical Designs, Inc. · Class II

Cleared under the same submission

K183263 also covers:

Dukal — Dukal LLC
Dukal — Dukal LLC
Unipack — Dukal LLC
Unipack — Dukal LLC
Unipack — Dukal LLC
Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
Unipack — Unipack Medical Corporation

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: Dukal LLC

Sources (1)

FDA UDI 6088a896-4a2e-4978-bfd6-2965ce19693a 36 fields · synced May 30, 2026