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Durex Intense

FDA UDI

Class II (US FDA UDI)

by RB Health (us) LLC

Identity

Trade Name
Durex Intense FDA UDI
Generic Name
Basic male condom, synthetic polymer FDA UDI
Device Name
10 ct. Durex Intense Nitrile Condom FDA UDI
Model / Reference
00302340995757 FDA UDI
Description
10 ct. Durex Intense Nitrile Condom FDA UDI

Identifiers

Primary DI / UDI-DI
00302340995757 FDA UDI
510(k) Number
K240896 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Basic male condom, synthetic polymer

Durex Intense by RB Health (us) 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

K240896 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
RB Health (us) LLC

Sources (1)

  • FDA UDI 89961b98-0bec-405a-85e4-2cae02bc7d15 34 fields · synced May 31, 2026