SKORE Dots Natural

GUDID 08906007135801

The SKORE Dots Natural condom is made of natural rubber latex. It is straight walled, dotted, teat ended, transparent 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 Dots Natural, 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 ID08906007135801
NIH Device Record Keye34cadd2-de00-4e6a-8011-b39539f60eb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSKORE Dots Natural
Version Model NumberSKORE Dots
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
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com
Phone+914442008231
Emailkalaivani.b@ttkhealthcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108906007135795 [Primary]
GS108906007135801 [Package]
Contains: 08906007135795
Package: Wallet [3 Units]
In Commercial Distribution
GS108906007135818 [Package]
Package: Carton [240 Units]
In Commercial Distribution
GS108906007135825 [Package]
Contains: 08906007135818
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 Date2023-07-11
Device Publish Date2023-07-03

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