FDA.reportPublic FDA data

TROJAN™ Premium Latex Condoms MAGNUM™ Large Size Condoms BareSkin™

Primary DI
00022600019763
Brand
TROJAN™ Premium Latex Condoms MAGNUM™ Large Size Condoms BareSkin™
Company
CHURCH & DWIGHT CO., INC.
Model
00022600019763
Published
2018-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCONDOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140379000MEGA BIG BOY CONDOMOkamoto USA, Inc.2014-07-01HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00022600019763PrimaryGS10
80022600228871Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00022600019763000226000197630226000197630022600019763
8002260022887180022600228871

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)833-9532Consumer.Relations@churchdwight.com

Regulatory Flags#

DUNS number
001211952
Device count
24
Lot or batch
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
00022600947219Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009472192016-10-14
00022600947325Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009473252016-10-13
00022600947400Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009474002016-10-13
00022600980506TROJAN™ NaturaLamb™ Luxury Condoms000226009805062016-10-13
00022600987536TROJAN™ NaturaLamb™ Luxury Condoms000226009875362016-10-13
00022600998440TROJAN™ NaturaLamb™ Luxury Condoms000226009984402016-10-13
00022600000600Trojan All The Feels Variety Pack000226000006002020-06-22
00022600000709Trojan All The Feels Variety Pack000226000007092020-07-29
00022600300007Trojan All the Feels Condom000226003000072020-06-10
00022600999492Trojan Variety Pack000226009994922020-07-15
00726893113985Trojan Ultra Thin Condoms007268931139852020-07-07
00726893113992Trojan Ultra Thin Condom007268931139922020-07-16
00726893114005Trojan Ultra Thin Condom007268931140052020-07-08
00726893114043Trojan Magnum007268931140432020-03-12
00726893114098Trojan Magnum Condom007268931140982020-03-27
00726893114104Trojan Enz007268931141042020-03-20
00726893800014Trojan Ultra Thin Condom007268938000142020-09-28
00726893800021Trojan Ultra Ribbed Condom007268938000212020-09-28
00726893800038Trojan Mangum Condom007268938000382020-09-28
00022600019831TROJAN 100CT BULK MIX000226000198312018-10-30

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