Ultra Shape Colors

GUDID 18859798104921

Ultra Shape Colors

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• Primary Device ID: 18859798104921
• NIH Device Record Key: e63b1136-4a4b-446d-b7cd-4a0cf4804602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra Shape Colors
• Version Model Number: 08859798104924
• Company DUNS: 672044515
• Company Name: SURETEX LIMITED - BRANCH
• Device Count: 1008
• 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: false

Customer Support Contacts

• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com
• Phone: 8482293224
• Email: alexandra.kirkland@lifestyles.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08859798104924 [Primary]
GS1	18859798104921 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941258

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: 2024-10-31
• Device Publish Date: 2024-10-23

Devices Manufactured by SURETEX LIMITED - BRANCH

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• 18859798107892 - SKYN: 2025-12-24 SKYN Original Non-Latex Condom BX40
• 18859798107946 - SKYN: 2025-12-24 SKYN Elite Large Non-Latex Condom BX12
• 18859798107960 - SKYN: 2025-12-24 SKYN COCKTAIL CLUB 36CT (CHERRY SUNRISE, PASSION DAIQUIRI, PINA COLADA)
• 18859798107977 - SKYN: 2025-12-24 SKYN Snug Fit 40ct
• 28859798108025 - SKYN: 2025-12-24 SKYN Elite Extra Lube Non-Latex Condom BX36
• 18859798108035 - SKYN: 2025-12-24 SKYN Elite Non-Latex Condom BX12
• 28859798108049 - SKYN: 2025-12-24 SKYN Elite Non-Latex Condom BX3