Ultra Shape Clear

GUDID 18859798104938

Ultra Shape Clear

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• Primary Device ID: 18859798104938
• NIH Device Record Key: 697846a1-bb22-447d-bd0e-625cff0607ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra Shape Clear
• Version Model Number: 08859798104931
• 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	08859798104931 [Primary]
GS1	18859798104938 [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

• 18859798104891 - ADAM & EVE: 2024-10-31 Adam & Eve - Hard Rider Condoms
• 18859798104907 - ADAM & EVE: 2024-10-31 Adam & Eve - Marathon condom
• 18859798104914 - ADAM & EVE: 2024-10-31 Adam & Eve - Ribbed Condom
• 18859798104921 - Ultra Shape Colors: 2024-10-31 Ultra Shape Colors
• 18859798104938 - Ultra Shape Clear: 2024-10-31Ultra Shape Clear
• 18859798104938 - Ultra Shape Clear: 2024-10-31 Ultra Shape Clear
• 18859798104945 - Ultra Shape Clear condom with NP9: 2024-10-31 Ultra Shape Clear condom with NP9 # 420
• 18859798104952 - STEAMWORKS NON LUBRICATED: 2024-10-31 STEAMWORKS NON LUBRICATED
• 18859798104969 - STEAMWORKS LUBRICATED CONDOM: 2024-10-31 STEAMWORKS LUBRICATED CONDOM