Merocel™

FDA UDI

Class U (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Merocel™ FDA UDI
Generic Name: Non-woven gauze pad FDA UDI
Device Name: DRESSING 470530 SINUSSTENT 20PK PAIR KEN FDA UDI
Model / Reference: 470530 FDA UDI
Description: DRESSING 470530 SINUSSTENT 20PK PAIR KEN FDA UDI

Identifiers

Primary DI / UDI-DI: 20763000617268 FDA UDI
FDA Product Code: EFQ FDA UDI
NAB FDA UDI
GMDN Term: Non-woven gauze pad FDA UDI

Classification

Device Class: U FDA UDI
Regulation Number: 878.4014 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

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 — 1.2 Centimeter FDA UDI
Height — 0.6 Centimeter FDA UDI
Length — 3.5 Centimeter FDA UDI

Category: Non-woven gauze pad

Merocel™ by Medtronic Xomed, Inc. — Class U — 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 U	Pending data

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI edf14999-9c68-4da0-84b4-0f652b3d2c8f 35 fields · synced Jun 1, 2026