FDA.reportPublic FDA data

Durex Intense

Primary DI
00302340995863
Brand
Durex Intense
Company
RB Health (us) LLC
Model
00302340995764
Device description
24 ct. Durex Intense Nitrile Condom
Published
2025-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MOLCondom, Synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOLCondom, SyntheticObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240896000ONE Nitrile CondomGlobal Protection Corp.2024-08-23MOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00302340995863PackageGS118In Commercial Distribution
00302340995764PrimaryGS10
99302340995744Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00302340995863003023409958633023409958630302340995863
00302340995764003023409957643023409957640302340995764
9930234099574499302340995744

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, synthetic polymerA sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081049410
Device count
24
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00302340894555DUREX Real Feel Non-Latex Condom003023408945552025-03-13
00302340894579DUREX Real Feel Non-Latex Condom003023408945792025-03-13
00302340908054DUREX Real Feel Non-Latex Condom003023409080542025-03-13
00302340894562DUREX Real Feel Non-Latex Condom003023408945622025-03-13
00302340996136Durex Intense003023409961362026-03-02
50302340996131Durex Intense003023409961362026-03-02
00067981089127KY Personal Lubricant Jelly000679810891272025-12-09
00067981089486KY Warming Jelly 000679810894862025-12-09
00067981952292KY Intense Pleasure Gel000679819522922025-12-09
00067981993691KY Personal Lubricant Jelly000679819936912025-12-09
00067981993738KY Personal Lubricant Jelly000679819937382025-12-09
00067981993967KY Natural Feeling with Hyaluronic Acid000679819939672025-12-09
00067981993974KY Natural Feeling with Hyaluronic Acid000679819939742025-12-09
00067981993981KY Natural Feeling with Aloe Vera Lubricant000679819939812025-12-09
00067981087956KY Personal Lubricant Jelly000679810890282025-12-09
00067981087963KY Personal Lubricant Jelly000679810891272025-12-09
10067981088059KY Warming Jelly 000679810894792025-12-09
10067981088042KY Warming Jelly 000679810894862025-12-09
10067981993698KY Personal Lubricant Jelly000679819936912025-12-09
10067981993964KY Natural Feeling with Hyaluronic Acid000679819939672025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859798108526SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108533SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108540SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108632SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108724SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108465SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
08859798108472SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
08859798108496SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108462SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108479SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108493SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
00302340996136Durex IntenseRB Health (us) LLCMOL2026-03-02
50302340996131Durex IntenseRB Health (us) LLCMOL2026-03-02
08859798108441SKYNSURETEX LIMITED - BRANCHMOL2026-01-27
08859798108069SKYNSURETEX LIMITED - BRANCHMOL2026-01-13
18859798108066SKYNSURETEX LIMITED - BRANCHMOL2026-01-13
08859798107888SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107895SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107949SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107963SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107970SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108021SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108038SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108045SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108052SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
18859798107885SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798106973SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
08859798107307SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
08859798107314SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
08859798107321SKYNSURETEX LIMITED - BRANCHMOL2025-09-04