SKORE Smooth Condoms - SKORE (Colors & Flavors)

GUDID 08906007135160

The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, smooth, teat ended, red colored, strawberry 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 (Colors & Flavors) 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

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Primary Device ID08906007135160
NIH Device Record Key76a64877-c521-46b0-b6a6-438b15dcd4dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSKORE Smooth Condoms - SKORE (Colors & Flavors)
Version Model NumberSKORE Strawberry
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+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108906007135153 [Primary]
GS108906007135160 [Package]
Contains: 08906007135153
Package: Wallet [3 Units]
In Commercial Distribution
GS108906007135177 [Package]
Package: Carton [240 Units]
In Commercial Distribution
GS108906007135184 [Package]
Contains: 08906007135177
Package: Case [2160 Units]
In Commercial Distribution

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 Date2023-07-06
Device Publish Date2023-06-28

On-Brand Devices [SKORE Smooth Condoms - SKORE (Colors & Flavors)]

08906007135320The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It i
08906007135283The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It i
08906007135245The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It i
08906007135207The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It i
08906007135160The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It i
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