Durex Intense

GUDID 00302340995856

10 ct. Durex Intense Nitrile Condom

RB Health (us) LLC

Basic male condom, synthetic polymer

• Primary Device ID: 00302340995856
• NIH Device Record Key: 89961b98-0bec-405a-85e4-2cae02bc7d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durex Intense
• Version Model Number: 00302340995757
• 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	00302340995757 [Primary]
GS1	00302340995856 [Package]; Contains: 00302340995757; Package: Case [18 Units]; In Commercial Distribution
GS1	99302340995744 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240896

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: 2025-01-29
• Device Publish Date: 2025-01-21

On-Brand Devices [Durex Intense]

• 00302340995863: 24 ct. Durex Intense Nitrile Condom
• 00302340995856: 10 ct. Durex Intense Nitrile Condom
• 00302340995870: 3 ct. Durex Intense Nitrile Condom