FDA.reportPublic FDA data

Trojan Enz 40 ct Bowl

Primary DI
00813356000125
Brand
Trojan Enz 40 ct Bowl
Company
PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
Model
813356000125
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901192000TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)Carter Products1990-04-16HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813356000125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813356000125008133560001258133560001250813356000125

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
038573838
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813356005014Crown Lubricated 500 ct Bag8133560050142025-11-11
00813356005069Crown Lubricated 250 ct Bag8133560050692025-11-11
00813356005137Kimono Bowl Microthin 40 ct Bowl8133560051372025-11-11
00813356005205Crown Lubricated 100 ct Bag8133560052052025-11-11
00813356005120Kimono Bowl Maxx Large Flare 40 ct Bowl8133560051202025-10-17
00813356005175Kimono Bowl Special 40 ct Bowl8133560051752025-10-17
00813356000064Lifestyles SKYN Elite 40 ct Bowl8133560000642025-09-11
00813356005380Paradise Super Thin 100 Condom704102025-09-05
00813356000040Paradise Slim Fit Condoms Strips 1000s706002019-07-08
00813356000057Paradise Slim Fit Condoms 40 ct bowl8133560000572019-07-08
00813356005366Paradise Super Thin 1000 Condom704002025-01-22
00813356000118Astroglide Personal Lubricant 40 ct bowl8133560001182018-12-21
00813356000002Paradise Lubricated Condoms Strips 1000s701002018-12-21
00813356000019Paradise Lubricated Condoms 40 ct bowl8133560000192018-12-21
00813356000033Lifestyles Rough Rider Studded 40 ct Bowl8133560000332019-04-23
00813356000132Trojan Magnum 40 ct Bowl8133560001322019-02-11
00813356000026Lover Covers Condoms 40 ct bowl8133560000262018-12-21
00813356000156Lifestyles Assorted Colors 40 ct Bowl8133560001562018-12-21
00813356000163LifeStyles Assorted Flavors 40 ct Bowl8133560001632018-12-21
00813356000170LifeStyles Extra Strength 40 ct Bowl8133560001702018-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
08859798108076LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798108083LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798107871LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03
19556807570843GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570867GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570881GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
08859798107260LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107277LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107284LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107291LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107383LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798104993PhillySURETEX LIMITED - BRANCHHIS2025-07-30
08859798105914LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798107130LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798106577LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106720LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106737LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106744LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106461LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-19
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106447LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106454LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106478LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106485LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106553LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106560LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08906007135351SKORE Dotted CondomsTTK HEALTHCARE LIMITEDHIS2025-01-31