PRUDENCE MIX C/3

GUDID 00812420030242

Contraceptive, condom, male 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

• Primary Device ID: 00812420030242
• NIH Device Record Key: 33c25909-5323-4b4d-94f5-f41fcae58be8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRUDENCE MIX C/3
• Version Model Number: Condom
• Company DUNS: 814851960
• Company Name: DKT de México, S.A. de C.V.
• 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: false
• 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	00812420030198 [Package]; Package: Case [3 Units]; In Commercial Distribution
GS1	00812420030242 [Primary]
GS1	10812420030195 [Package]; Contains: 00812420030198; Package: Inner [12 Units]; In Commercial Distribution
GS1	20812420030192 [Package]; Contains: 10812420030195; Package: Box [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041837

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: 2020-02-24
• Device Publish Date: 2020-02-14

Devices Manufactured by DKT de México, S.A. de C.V.

• 00812420030228 - PRUDENCE CLASSIC C/12: 2020-02-24 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
• 00812420030211 - PRUDENCE SENSITIVE C/12: 2020-02-24 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
• 00812420030242 - PRUDENCE MIX C/3: 2020-02-24Contraceptive, condom, male 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.
• 00812420030242 - PRUDENCE MIX C/3: 2020-02-24 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
• 00812420030181 - PRUDENCE BANANA: 2020-01-29 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
• 00812420030259 - PRUDENCE MIX C/12: 2020-01-29 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
• 10812420030188 - PRUDENCE BANANA: 2020-01-29 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
• 20812420030185 - PRUDENCE BANANA: 2020-01-29 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
• 10812420030010 - Prudence Mint: 2019-11-22 Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm