SKORE Bulbous Condoms

GUDID 08906007135566

The SKORE Bulbous Condoms - SKORE Warm condom is made of natural rubber latex. It is straight walled, bulbous, teat ended, orange colored male condoms lubricated with silicone oil and warm lubricant. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Bulbous Condoms - SKORE Warm natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

TTK HEALTHCARE LIMITED

Basic male condom, Hevea-latex
Primary Device ID08906007135566
NIH Device Record Key64422298-e3de-4166-9892-6f968eee0c8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSKORE Bulbous Condoms
Version Model NumberSKORE Warm
Company DUNS675476406
Company NameTTK HEALTHCARE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com
Phone+914442004231
Emailkaliavani.b@ttkhealthcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108906007135559 [Primary]
GS108906007135566 [Package]
Contains: 08906007135559
Package: Wallet [3 Units]
In Commercial Distribution
GS108906007135573 [Package]
Package: Carton [240 Units]
In Commercial Distribution
GS108906007135580 [Package]
Contains: 08906007135573
Package: Case [2160 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-10
Device Publish Date2025-01-31

On-Brand Devices [SKORE Bulbous Condoms]

08906007135603The SKORE Bulbous Condoms - SKORE Cool condom is made of natural rubber latex. It is straight wa
08906007135566The SKORE Bulbous Condoms - SKORE Warm condom is made of natural rubber latex. It is straight wa

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