ADAM & EVE

GUDID 18859798104891

Adam & Eve - Hard Rider Condoms

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• Primary Device ID: 18859798104891
• NIH Device Record Key: 6cff393e-7b19-42ae-b3cf-96328c36b12b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAM & EVE
• Version Model Number: 08859798104894
• 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	08859798104894 [Primary]
GS1	18859798104891 [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

On-Brand Devices [ADAM & EVE]

• 18859798104914: Adam & Eve - Ribbed Condom
• 18859798104907: Adam & Eve - Marathon condom
• 18859798104891: Adam & Eve - Hard Rider Condoms