FDA.reportPublic FDA data

m. Dior

Primary DI
00692563400122
Brand
m. Dior
Company
Suzhou Colourway New Material Co., Ltd.
Model
53±2mm
Published
2025-03-27
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083817000M. DIOR BRANDSuzhou Colour-Way Enterprise Development Co., Ltd.2009-09-16HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00692563400122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00692563400122006925634001226925634001220692563400122

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, Hevea-latexA Hevea-latex rubber sheath 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
544612070
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925634004245RogitarStrawberry Flavored, large (55±2mm) thickness: 0.02026-06-10
06925634004252RogitarChocolate Flavored, large (55±2mm) thickness: 0.062026-06-10
06925634004269RogitarCherry Flavored, large (55±2mm) thickness: 0.065 ±2026-06-10
06925634004276RogitarUltraThin, large (55±2mm) thickness: 0.045 ± 0.0152026-06-10
06925634004283RogitarHyaluronic Acid, large (55±2mm) thickness: 0.065 ±2026-06-10
06925634004290RogitarExtended Pleasure, medium(53±2mm) thickness: 0.0652026-06-10
06925634004177AowawoStrawberry flavor, large (55±2mm) thickness: 0.0652026-03-02
06925634004214AowawoStrawberry flavor, extra dotted, medium (53±2mm), 2026-03-02
06925634004221AowawoStrawberry flavor, Ribbed, medium (53±2mm), thick2026-03-02
06925634004238AowawoStrawberry flavor, Ultra-thin, medium (53±2mm), t2026-03-02
00860014772207DOGTAG CONDOMSRibbed, medium (53±2mm) thickness: 0.065 ± 0.015mm2025-12-17
00860014772214DOGTAG CONDOMSRibbed, medium (53±2mm) thickness: 0.065 ± 0.015mm2025-12-17
06925634004139GETANERibbed and Studded Condoms,medium(53 ± 2mm) thickn2025-10-24
06925634004146GETANE Large size Super smooth and moisturizing Male, la2025-10-24
06925634004153GETANE Large size Orange flavor Male, large (55 ± 2mm) t2025-10-24
06925634004160GETANE Large size Ultra-thin, large (55 ± 2mm) thickness2025-10-24
06925634004184JIAOYUEExtra Dotted Latex Male Condoms, medium (53±2mm) t2025-10-24
06925634004207GETANE Large size Strawberry flavor Male, large (55 ± 2m2025-10-24
06925634009011Aowawo3 in 1 Male Latex Condoms, medium (53 ± 2mm) thick2025-08-21
06925634004504GETANE Extra Dotted Condoms, medium (53 ± 2mm) thickness2025-06-10