SKORE (Colors & Flavors)

GUDID 08906007134927

The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dotted, teat ended, red colored, cherry 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(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

Basic male condom, Hevea-latex

• Primary Device ID: 08906007134927
• NIH Device Record Key: 6be03264-8a1b-4c79-830b-e17debdb44a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKORE (Colors & Flavors)
• Version Model Number: SKORE Cherry
• 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	08906007134910 [Primary]
GS1	08906007134927 [Package]; Contains: 08906007134910; Package: Wallet [3 Units]; In Commercial Distribution
GS1	08906007134934 [Package]; Package: Carton [240 Units]; In Commercial Distribution
GS1	08906007134941 [Package]; Contains: 08906007134934; 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 & Flavors)]

• 08906007134965: The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dott
• 08906007134927: The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dott
• 08906007134880: The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dott
• 08906007135122: The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dott
• 08906007135085: The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dott
• 08906007135047: The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dott
• 08906007135009: The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dott