Dukal

FDA UDI

Class I (US FDA UDI)

by Dukal LLC

Identity

Trade Name: Dukal FDA UDI
Generic Name: Skin-closure adhesive strip FDA UDI
Device Name: DK 1/4"x4" Wound Close Strp ST FDA UDI
Model / Reference: 5156 FDA UDI
Description: DK 1/4"x4" Wound Close Strp ST FDA UDI

Identifiers

Catalog Number: 5156 FDA UDI
Primary DI / UDI-DI: 10665973008827 FDA UDI
510(k) Number: K931005 FDA UDI
FDA Product Code: FPX FDA UDI
GMDN Term: Skin-closure adhesive strip FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5240 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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: Skin-closure adhesive strip

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

Similar devices

Also classified as Skin-closure adhesive strip.

UC Strip™ — Derma Sciences Canada, Inc · Class I
3M™ Steri-Strip™ — 3M COMPANY · Class I
Suture Strip® — Derma Sciences Canada, Inc · Class I
3M™ Steri-Strip™ — 3M COMPANY · Class I
BContak — BRIDON, CORP. · Class III
3M™ Steri-Strip™ — 3M COMPANY · Class I
CareOne — Ahold U.S.A., Inc. · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I

Cleared under the same submission

K931005 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 I	Pending data

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Manufacturer

Manufacturer: Dukal LLC

Sources (1)

FDA UDI bd04ede8-63e0-4294-be1a-ef5ef181dcc0 36 fields · synced May 29, 2026