Bikini

GUDID 08859798105020

Bikini CONDOM 1ct

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• Primary Device ID: 08859798105020
• NIH Device Record Key: 9b9b5b5f-0383-4e12-b994-3f3deac54b9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bikini
• Version Model Number: 08859798105020
• Company DUNS: 672044515
• Company Name: SURETEX LIMITED - BRANCH
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08859798105020 [Primary]

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: 2025-08-07
• Device Publish Date: 2025-07-30

Devices Manufactured by SURETEX LIMITED - BRANCH

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• 08859798105006 - LifeStyles: 2025-08-07 LifeStyles Pleasure Ribbed 1ct
• 08859798105013 - Rough Rider: 2025-08-07 Rough Rider 1ct
• 08859798105020 - Bikini: 2025-08-07Bikini CONDOM 1ct
• 08859798105020 - Bikini: 2025-08-07 Bikini CONDOM 1ct
• 08859798105037 - Savage Bliss: 2025-08-07 Savage Bliss 1ct
• 28859798105918 - LifeStyles: 2025-08-07 LifeStyles Variety Pack Latex Condom BX144 RP
• 08859798106584 - SKYN: 2025-08-07 SKYN Elite 36ct
• 28859798106960 - SKYN: 2025-08-07