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Leader

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 110, Inc.

Identity

Trade Name
LEADER FDA UDI
Generic Name
Non-woven gauze pad FDA UDI
Device Name
Non-Stick Pads For Covering Wounds; Triple Layer Protection Won't Stick to Wounds; Latex Free; All One Size 3 IN. x 4 IN. FDA UDI
Model / Reference
3463122 FDA UDI
Description
Non-Stick Pads For Covering Wounds; Triple Layer Protection Won't Stick to Wounds; Latex Free; All One Size 3 IN. x 4 IN. FDA UDI

Identifiers

Catalog Number
3463122 FDA UDI
Primary DI / UDI-DI
00096295111712 FDA UDI
FDA Product Code
NAC FDA UDI
GMDN Term
Non-woven gauze pad FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4018 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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: Non-woven gauze pad

Leader by Cardinal Health 110, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-woven gauze pad.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 97ae3b08-5e6f-4a16-8cb8-192816402bb2 35 fields · synced May 30, 2026