SKORE (Colors)

GUDID 08906007134712

The SKORE (Colors) is made of natural rubber latex. It is smooth, straight walled, teat ended, red colored 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(Colors) 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 ID: 08906007134712
• NIH Device Record Key: 376e5eec-7910-405f-8c63-34fea130fd6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKORE (Colors)
• Version Model Number: SKORE Red
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08906007134712 [Primary]
GS1	08906007134729 [Package]; Package: Wallet [3 Units]; In Commercial Distribution
GS1	08906007134736 [Package]; Contains: 08906007134729; Package: carton [240 Units]; In Commercial Distribution
GS1	08906007134743 [Package]; Contains: 08906007134736; Package: case [2160 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202403

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: 2023-07-05
• Device Publish Date: 2023-06-27

On-Brand Devices [SKORE (Colors)]

• 08906007134842: The SKORE (Colors) is made of natural rubber latex. It is smooth, straight walled, teat ended, o
• 08906007134804: The SKORE (Colors) is made of natural rubber latex. It is smooth, straight walled, teat ended, b
• 08906007134767: The SKORE (Colors) is made of natural rubber latex. It is smooth, straight walled, teat ended, y
• 08906007134712: The SKORE (Colors) is made of natural rubber latex. It is smooth, straight walled, teat ended, r