FDA.reportPublic FDA data

SKORE BULBOUS DOTS AND RIBS

Primary DI
08906007131711
Brand
SKORE BULBOUS DOTS AND RIBS
Company
TTK HEALTHCARE LIMITED
Model
BULBOUS DOTS AND RIBS
Device description
The SKORE Bulbous Dots & Ribs Natural is made of natural rubber latex.It is a bulbous teat ended, fully textured, transparent male condom. It meets the requirements as specified in ASTM D 3492 standard for rubber latex contraceptives (Male condoms). The Skore bulbous dots and ribs natural rubber latex condoms are used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases).
Published
2016-10-03
Public version status
Update
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
K132490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132490000SKORE AND MULTIPLE BRANDSTtk Protective Devices Limited (Formerly Ttk-Lig L2014-10-20HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906007131728PackageGS1240In Commercial Distribution
08906007131735PackageGS12160In Commercial Distribution
08906007131711PrimaryGS10
08906007131827Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906007131728089060071317288906007131728
08906007131735089060071317358906007131735
08906007131711089060071317118906007131711
08906007131827089060071318278906007131827

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
+914442008231kalaivani.b@ttkpdl.com
+914442008200vijayaraghavan.st@ttkpdl.com

Regulatory Flags#

DUNS number
675476406
Device count
3
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
08906007135351SKORE Dotted CondomsSKORE Belgian Chocolate2025-01-31
08906007135399SKORE Dotted CondomsSKORE Dots - Vanilla2025-01-31
08906007135436SKORE Thin Condoms with FlavorsSKORE NOTHING Strawberry2025-01-31
08906007135474SKORE Thin Condoms with FlavorsSKORE NOTHING Chocolate2025-01-31
08906007135511SKORE Thin Condoms with FlavorsSKORE SKINTHIN2025-01-31
08906007135559SKORE Bulbous CondomsSKORE Warm2025-01-31
08906007135597SKORE Bulbous CondomsSKORE COOL2025-01-31
08906007135634SKORE Benzocaine CondomsSKORE NOTHING Climax Delay2025-01-31
08906007135672SKORE Benzocaine CondomsSKORE DUO MAX2025-01-31
08906007135719SKORE Benzocaine CondomsSKORE NOT OUT Climax Delay2025-01-31
08906007135870SKORE Smooth CondomsSKORE Blues - Vanilla2025-01-31
08906007135368SKORE Dotted CondomsSKORE Belgian Chocolate2025-01-31
08906007135405SKORE Dotted CondomsSKORE Dots - Vanilla2025-01-31
08906007135443SKORE Thin Condoms with FlavorsSKORE NOTHING Strawberry2025-01-31
08906007135481SKORE Thin Condoms with FlavorsSKORE NOTHING Chocolate2025-01-31
08906007135528SKORE Thin Condoms with FlavorsSKORE SKINTHIN2025-01-31
08906007135566SKORE Bulbous CondomsSKORE Warm2025-01-31
08906007135603SKORE Bulbous CondomsSKORE COOL2025-01-31
08906007135641SKORE Benzocaine CondomsSKORE NOTHING Climax Delay2025-01-31
08906007135689SKORE Benzocaine CondomsSKORE DUO MAX2025-01-31

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Primary DI, Brand, Company table
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08852961033212Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-06-25
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