Durex Intense XL

GUDID 00302340995931

10 ct. Durex Intense XL Nitrile Condom

RB Health (us) LLC

Basic male condom, synthetic polymer

• Primary Device ID: 00302340995931
• NIH Device Record Key: da42150c-8281-4ec6-996b-25cbde8b1843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durex Intense XL
• Version Model Number: 00302340995825
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 10
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00302340995825 [Primary]
GS1	00302340995931 [Package]; Contains: 00302340995825; Package: Case [18 Units]; In Commercial Distribution
GS1	99302340995997 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243967

FDA Product Code

• MOL: Condom, Synthetic

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: 2025-09-09
• Device Publish Date: 2025-09-01

On-Brand Devices [Durex Intense XL]

• 50302340996001: 24 ct. Durex Intense XL Nitrile Condom
• 50302340995998: 3 ct. Durex Intense XL Nitrile Condom
• 00302340995931: 10 ct. Durex Intense XL Nitrile Condom