CARE

GUDID 08809822510566

CARE LATEX INTERNATIONAL US INC

Basic male condom, Hevea-latex

• Primary Device ID: 08809822510566
• NIH Device Record Key: 677881df-43f9-46b9-b9ea-97eaff19a32d
• Commercial Distribution Discontinuation: 2025-04-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CARE
• Version Model Number: 38 Ultimate Ribbed
• Company DUNS: 134211144
• Company Name: CARE LATEX INTERNATIONAL US INC
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809822510566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020272

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: 2025-04-29
• Device Publish Date: 2025-04-21

On-Brand Devices [CARE]

• 08809822510580: 55 G-Spot Mint
• 08809822510573: 48 Spotted Sensation
• 08809822510566: 38 Ultimate Ribbed
• 08809822510559: 29 XL Vanilla