SKORE Bulbous Condoms

GUDID 08906007135603

The SKORE Bulbous Condoms - SKORE Cool condom is made of natural rubber latex. It is straight walled, bulbous, teat ended, blue colored male condoms lubricated with silicone oil and cool tropic mint flavor. 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 Cool 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 ID: 08906007135603
• NIH Device Record Key: e5ebca9a-613f-4295-bed5-0d073aedf875
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKORE Bulbous Condoms
• Version Model Number: SKORE COOL
• Company DUNS: 675476406
• Company Name: TTK HEALTHCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com
• Phone: +914442008231
• Email: kalaivani.b@ttkhealthcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08906007135597 [Primary]
GS1	08906007135603 [Package]; Contains: 08906007135597; Package: Wallet [3 Units]; In Commercial Distribution
GS1	08906007135610 [Package]; Package: Carton [240 Units]; In Commercial Distribution
GS1	08906007135627 [Package]; Contains: 08906007135610; Package: Case [2160 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230049

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-10
• Device Publish Date: 2025-01-31

On-Brand Devices [SKORE Bulbous Condoms]

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