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Kimono Swirl

FDA UDI

Class II (US FDA UDI)

by Mayer Laboratories

Identity

Trade Name
Kimono Swirl FDA UDI
Generic Name
Sexual lubricant FDA UDI
Device Name
Personal Lubricant - Silicone 100 ml FDA UDI
Model / Reference
Swirl Silcone Lubricant FDA UDI
Description
Personal Lubricant - Silicone 100 ml FDA UDI

Identifiers

Catalog Number
54104 FDA UDI
Primary DI / UDI-DI
00016169541049 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 100 Milliliter FDA UDI

Category: Sexual lubricant

Kimono Swirl by Mayer Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sexual lubricant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mayer Laboratories

Sources (1)

  • FDA UDI 554b128b-75d6-4a8b-bead-78cb0e54374c 37 fields · synced May 30, 2026