STEAMWORKS NON LUBRICATED CONDOM

GUDID 18859798104976

STEAMWORKS NON LUBRICATED CONDOM

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• Primary Device ID: 18859798104976
• NIH Device Record Key: d8a4cc37-4410-4844-9758-80c708c231bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STEAMWORKS NON LUBRICATED CONDOM
• Version Model Number: 08859798104979
• 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	08859798104979 [Primary]
GS1	18859798104976 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940046

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

• 18859798105461 - SKYN: 2024-12-26 SKYN KING Elite Large Extra Glide Non-Latex Condom BX03
• 18859798105478 - SKYN: 2024-12-26 SKYN KING Large Non-Latex Condom BX03
• 08859798105778 - SKYN: 2024-12-26 SKYN Supreme Feel Non-Latex Condom BX01
• 18859798105829 - SKYN: 2024-12-26 SKYN Elite Large Non-Latex Condom BX36 RP
• 18859798105836 - SKYN: 2024-12-26 SKYN Elite Non-Latex Condom BX36 AMAZON RP
• 18859798105874 - SKYN: 2024-12-26 SKYN Supreme Feel Non-Latex Condom BX03 TP
• 18859798105881 - SKYN: 2024-12-26 SKYN Supreme Feel Non-Latex Condom 1008
• 08859798105891 - SKYN: 2024-12-26 SKYN SUPREME FEEL NON-LATEX CONDOM BX01 RP