SKORE (Colors & Flavors)

Basic Information

• Brand Name: SKORE (Colors & Flavors)
• Primary DI: 08906007134873
• Version / Model: SKORE Strawberry
• Company Name: TTK HEALTHCARE LIMITED
• Labeler DUNS: 675476406
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-27
• Public Version: 1
• Public Version Date: 2023-07-05
• Public Version Status: New
• Public Device Record Key: 6ac7bdc9-c1d2-4d18-a783-27c2897b69d3

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIS	Condom	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45138	Basic male condom, Hevea-latex	A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08906007134880	GS1	Wallet	3	In Commercial Distribution
Primary	08906007134873	GS1
Package	08906007134897	GS1	Carton	240	In Commercial Distribution
Package	08906007134903	GS1	Case	2160	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K202403	000