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Dukal

FDA UDI

Class I (US FDA UDI)

by Dukal LLC

Identity

Trade Name
Dukal FDA UDI
Generic Name
Woven gauze roll/sheet FDA UDI
Device Name
Rolled Gauze 6" x 5 yd 2-Ply, Non-Sterile FDA UDI
Model / Reference
406 FDA UDI
Description
Rolled Gauze 6" x 5 yd 2-Ply, Non-Sterile FDA UDI

Identifiers

Catalog Number
406 FDA UDI
Primary DI / UDI-DI
10665973015436 FDA UDI
FDA Product Code
NAB FDA UDI
GMDN Term
Woven gauze roll/sheet FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4014 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Woven gauze roll/sheet

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

Similar devices

Also classified as Woven gauze roll/sheet.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dukal LLC

Sources (1)

  • FDA UDI ce8fd7f4-ea83-465e-876b-19e5fb42dd5a 35 fields · synced May 31, 2026