Lifestyles

FDA UDI

Class II (US FDA UDI)

by Suretex Limited - Branch

Identity

Trade Name: Lifestyles FDA UDI
Generic Name: Basic male condom, synthetic polymer FDA UDI
Device Name: Lifestyles Premium Pack (contains Ultra Sensitive, SKYN Elite, Ultra Ribbed) FDA UDI
Model / Reference: 5394 FDA UDI
Description: Lifestyles Premium Pack (contains Ultra Sensitive, SKYN Elite, Ultra Ribbed) FDA UDI

Identifiers

Primary DI / UDI-DI: 00070907253946 FDA UDI
FDA Product Code: MOL FDA UDI
HIS FDA UDI
GMDN Term: Basic male condom, synthetic polymer 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

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Basic male condom, Hevea-latex Basic male condom, synthetic polymer

Lifestyles by Suretex Limited - Branch — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic male condom, synthetic polymer.

Bioseal Inc. — BIOSEAL · Class I
Durex Intense — RB Health (us) LLC · Class II
Bioseal Inc. — BIOSEAL · Class I
Trojan Raw - Non Latex — Church & Dwight Co., Inc. · Class II
Lifestyles — LUNAMAX LLC · Class II
SKYN — LIL DRUG STORE PRODUCTS, INC. · Class II
LifeStyles SKYN Original 40 ct Bowl — PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION · Class II
Durex Intense Ultra Lube — RB Health (us) LLC · Class II

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: Suretex Limited - Branch

Sources (1)

FDA UDI 468d8379-e1d8-457c-b1cd-07b53c73a953 33 fields · synced Jun 8, 2026