| Primary Device ID | 00812420030211 |
| NIH Device Record Key | 5f88a475-3e33-46c3-ab5e-e7b02115555d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRUDENCE SENSITIVE C/12 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00812420030211 [Package] Contains: 10812420030096 Package: Case [12 Units] In Commercial Distribution |
| GS1 | 10812420030096 [Primary] |
| GS1 | 10812420030218 [Package] Package: Inner [6 Units] In Commercial Distribution |
| GS1 | 20812420030215 [Package] Contains: 10812420030218 Package: Box [24 Units] In Commercial Distribution |
| HIS | Condom |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2020-02-14 |
| 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 | 2020-02-24Contraceptive, 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. |
| 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 | 2020-02-24 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 |