DOGTAG CONDOMS

GUDID 00860014772207

Suzhou Colourway New Material Co., Ltd.

Basic male condom, Hevea-latex

• Primary Device ID: 00860014772207
• NIH Device Record Key: 3a7e81fd-28ed-4bdd-97f9-3e5f72623a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOGTAG CONDOMS
• Version Model Number: Ribbed, medium (53±2mm) thickness: 0.065 ± 0.015mm
• 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: 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	00860014772207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222611

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: 2025-12-25
• Device Publish Date: 2025-12-17

On-Brand Devices [DOGTAG CONDOMS]

• 00860014772214: Ribbed, medium (53±2mm) thickness: 0.065 ± 0.015mm
• 00860014772207: Ribbed, medium (53±2mm) thickness: 0.065 ± 0.015mm