FDA.reportPublic FDA data

ID Condoms

Primary DI
60761236901098
Brand
ID Condoms
Company
WESTRIDGE LABORATORIES INCORPORATED
Model
ID Studded Condoms (3-pack)
Catalog number
IDDCST03
Device description
Premium lubricated Latex Condom
Published
2017-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
K910284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910284000CONDOMS (RUBBER CONTRACEPTIVES)Suretex, Ltd.1991-06-04HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60761236901098PackageGS124In Commercial Distribution
00761236901096PrimaryGS10
00761236110221Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6076123690109860761236901098
00761236901096007612369010967612369010960761236901096
00761236110221007612361102217612361102210761236110221

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

Contacts#

Phone, Email table
PhoneEmail
17142599400service@westridgelabs.com

Regulatory Flags#

DUNS number
879057065
Device count
3
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195893640959Analcaine Kick Ass Lube WB 4ozAnalcaine Kick Ass Lube WB 4ozIDD115262023-04-12
00651277000691Travel Assets 7.5ml Foil Water Based Cock OilTravel Assets 7.5ml Foil Water Based Cock OilIDD11A002023-04-12
00850013816040CHAMP 4.4 fl oz Water Based BottleCHAMP 4.4 fl oz Water Based BottleIDD113952023-04-24
00850013816057CHAMP 1 fl oz Water Based BottleCHAMP 1 fl oz Water Based BottleIDD113942023-04-24
00858291006061Obsess Me Water Based Lubricant 16 ozObsess Me Water Based Lubricant 16 oz2023-04-12
00858291006054Obsess Me Water Based Lubricant 8.5 ozObsess Me Water Based Lubricant 8.5 oz2023-04-12
00858291006078Obsess Me Water Based Lubricant 32 ozObsess Me Water Based Lubricant 32 ozIDD11B032023-04-12
00858291006085Obsess Me Toy Cleaner Bottle 8.1ozObsess Me Toy Cleaner Bottle 8.1ozIDD11B042023-04-25
00761236902604FAVFAV 33.5 fl oz WB BottleIDD200022026-02-11
00761236903571FAVFAV 12oz Anal LubricantIDD200042026-02-11
00761236902598FAV8.25 fl oz WB BottleIDD200012026-02-09
90761236902591FAV8.25 fl oz WB BottleIDD200012026-02-09
00761236903427ID Totally NakedID Totally Naked 4ml FoilIDDFNF04AA2025-10-29
00761236903274ID Sex GreaseID Sex Grease 4.4oz Water BasedIDDGTB04AA2025-10-28
00761236903281ID Sex GreaseSex Grease 8.5 fl oz Water BasedIDDGTB08AA2025-10-28
00761236903298ID Sex GreaseID Seax Grease 4.4 fl oz Silicone BasedIDDGSB04AA2025-10-28
00761236903311ID Sex GreaseSex Grease 8.5 fl oz Silicone BasedIDDGSB08AA2025-10-28
00761236903403ID SensationID Sensation 4 ml FoilIDDSEF04AA2025-10-28
00761236904035ID Toy LubeID Toy Lube 4.4oz IDDWTL04AA2025-10-28
00761236903267ID Sex GreaseID Sex Grease 4 ml Foil Water BasedIDDGTF04AA2025-10-22

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08852961028935Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-07-22
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08852961033205Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-06-25
08852961033212Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-06-25
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