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Lifestyles

FDA UDI

Class II (US FDA UDI)

by Lunamax Llc

Identity

Trade Name
Lifestyles FDA UDI
Generic Name
Basic male condom, synthetic polymer FDA UDI
Device Name
Lifestyles SKYN Polyisoprene/Synthetic Condom FDA UDI
Model / Reference
GS100B FDA UDI
Description
Lifestyles SKYN Polyisoprene/Synthetic Condom FDA UDI

Identifiers

Primary DI / UDI-DI
00850002174038 FDA UDI
510(k) Number
K160399 FDA UDI
FDA Product Code
MOL 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

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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Basic male condom, synthetic polymer

Lifestyles by Lunamax Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic male condom, synthetic polymer.

Cleared under the same submission

K160399 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lunamax Llc

Sources (1)

  • FDA UDI 59738eaa-45e1-47cb-9dd9-8726d1cdff56 34 fields · synced Jun 8, 2026