Leader

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 110, Inc.

Identity

Trade Name: LEADER FDA UDI
Generic Name: Sexual lubricant FDA UDI
Device Name: LDR Lubricating Jelly 4oz FDA UDI
Model / Reference: 5851845 FDA UDI
Description: LDR Lubricating Jelly 4oz FDA UDI

Identifiers

Catalog Number: 5851845 FDA UDI
Primary DI / UDI-DI: 00096295142860 FDA UDI
510(k) Number: K180923 FDA UDI
FDA Product Code: NUC FDA UDI
GMDN Term: Sexual lubricant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5300 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sexual lubricant

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

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Cleared under the same submission

K180923 also covers:

Careone — Ahold U.S.A., Inc.
HEB — H. E. BUTT GROCERY COMPANY
Good Sense — L PERRIGO COMPANY
Meijer Personal Lubricant — MEIJER, INC.
PUBLIX Personal Lubricant — PUBLIX SUPER MARKETS, INC.
Equaline — SUPERVALU INC.
Up & Up — TARGET CORPORATION
Walgreens — WALGREEN CO.

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 II	Pending data

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Manufacturer

Manufacturer: Cardinal Health 110, Inc.

Sources (1)

FDA UDI 07f80c53-9862-4545-ad6c-c9d55fb48c52 37 fields · synced Jun 8, 2026