Prudence Sensitive

GUDID 20812420030048

Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

DKT de México, S.A. de C.V.

Basic male condom, Hevea-latex Basic male condom, Hevea-latex

• Primary Device ID: 20812420030048
• NIH Device Record Key: d4bb3e6f-3375-4b28-84c9-280eac7cd547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prudence Sensitive
• Version Model Number: Condom
• Company DUNS: 814851960
• Company Name: DKT de México, S.A. de C.V.
• Device Count: 48
• 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: false
• 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	00812420030099 [Unit of Use]
GS1	20812420030048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012665

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-22
• Device Publish Date: 2018-06-20

On-Brand Devices [Prudence Sensitive]

• 00812420030044: Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the peni
• 20812420030048: Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the peni