m. Dior

GUDID 00692563400122

Suzhou Colourway New Material Co., Ltd.

Basic male condom, Hevea-latex

• Primary Device ID: 00692563400122
• NIH Device Record Key: 5f245cfd-abfd-4db7-9733-c9791cc77102
• Commercial Distribution Discontinuation: 2025-03-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: m. Dior
• Version Model Number: 53±2mm
• Company DUNS: 544612070
• Company Name: Suzhou Colourway New Material Co., Ltd.
• 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: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	00692563400122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083817

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: 2025-04-04
• Device Publish Date: 2025-03-27

On-Brand Devices [m. Dior]

• 00692563400122: 53±2mm
• 06925634004054: Dotted, medium (53 ± 2mm) thickness: 0.045 ± 0.008