SKORE Smooth Condoms

GUDID 08906007135887

The SKORE Smooth Condoms - SKORE Blues- Vanilla condom is made of natural rubber latex. It is straight walled, smooth, teat ended, blue colored, vanilla flavored male condoms. 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 Smooth Condoms - SKORE Blues-Vanilla natural rubber latex male 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 ID08906007135887
NIH Device Record Key61b25af2-dace-45e4-9063-d6ddccd5282b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSKORE Smooth Condoms
Version Model NumberSKORE Blues - Vanilla
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+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com
Phone+91444200831
Emailkalaivani.b@ttkhealthcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108906007135870 [Primary]
GS108906007135887 [Package]
Contains: 08906007135870
Package: Wallet [3 Units]
In Commercial Distribution
GS108906007135894 [Package]
Package: Carton [240 Units]
In Commercial Distribution
GS108906007135900 [Package]
Contains: 08906007135894
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

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