Dermacea

FDA UDI

Class I (US FDA UDI)

by Cardinalhealth

Identity

Trade Name: Dermacea FDA UDI
Generic Name: Woven gauze pad, non-antimicrobial FDA UDI
Device Name: Gauze Sponges,16 Ply FDA UDI
Model / Reference: 441216 FDA UDI
Description: Gauze Sponges,16 Ply FDA UDI

Identifiers

Catalog Number: 441216 FDA UDI
Primary DI / UDI-DI: 10884521066083 FDA UDI
FDA Product Code: FRL FDA UDI
GMDN Term: Woven gauze pad, non-antimicrobial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5300 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 4 Inch FDA UDI
Length — 4 Inch FDA UDI

Category: Woven gauze pad, non-antimicrobial

Dermacea by Cardinalhealth — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Cardinalhealth

Sources (1)

FDA UDI 7ab65461-fc4f-4b74-a416-f357dad1b1c3 37 fields · synced May 31, 2026