| Primary Device ID | 08016867006743 |
| NIH Device Record Key | eb04a43c-fd32-494f-a97c-a67fdfa3e662 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Azalea Tampons |
| Version Model Number | Applicator Regular |
| Company DUNS | 428129167 |
| Company Name | CORMAN SPA |
| Device Count | 16 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08016867006743 [Primary] |
| GS1 | 18016867006740 [Unit of Use] |
| GS1 | 38016867006744 [Package] Package: [12 Units] In Commercial Distribution |
| GS1 | 48016867006741 [Package] Package: [6 Units] In Commercial Distribution |
| HEB | Tampon, Menstrual, Unscented |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2016-09-21 |
| 38016867007925 | The box contains two types of tampons (8+8) offered in two adsorbencies: Regular and Super. Each |
| 38016867007918 | Applicator Biobased SUPER |
| 38016867007901 | Applicator Biobased REGULAR |
| 08016867006750 | Applicator Super |
| 08016867006743 | Applicator Regular |
| 08016867006736 | No Applicator Super |
| 08016867006729 | No Applicator Regular |