KY Silicone

FDA UDI

Class II (US FDA UDI)

by RB Health (us) LLC

Identity

Trade Name: KY Silicone FDA UDI
Generic Name: Vaginal lubricant FDA UDI
Device Name: Personal Lubricants: Product Sizes are 0.16oz, 1.5oz, 4.5oz, 8.45oz FDA UDI
Model / Reference: Personal Lubricant FDA UDI
Description: Personal Lubricants: Product Sizes are 0.16oz, 1.5oz, 4.5oz, 8.45oz FDA UDI

Identifiers

Primary DI / UDI-DI: 99067981941832 FDA UDI
510(k) Number: K173504 FDA UDI
FDA Product Code: NUC FDA UDI
GMDN Term: Vaginal 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

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

FDA UDI

Category: Vaginal lubricant

KY Silicone by RB Health (us) LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vaginal lubricant.

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2.5 oz Silky Moisture Personal Lubricant — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
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CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
Aloe Cadabra — Live Well Brands, INC. · Class II

Cleared under the same submission

K173504 also covers:

Durex Cheeky Play Silicone Long Lasting Pleasure/Durex Cheeky Play Silicone — RB Health (us) LLC

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: RB Health (us) LLC

Sources (1)

FDA UDI 0f107195-09ba-497d-a065-e9a7d02cb9d0 36 fields · synced May 30, 2026