| Primary Device ID | 38016867009912 |
| NIH Device Record Key | 9348813e-1d10-4e5c-851c-bbcc98f07934 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORGANYC |
| Version Model Number | No Applicator Super |
| 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 | true |
| 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 | 08016867009911 [Primary] |
| GS1 | 18016867009918 [Unit of Use] |
| GS1 | 38016867009912 [Package] Contains: 08016867009911 Package: [12 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 |
| 38016867009929 | No Applicator Regular |
| 38016867009912 | No Applicator Super |
| 38016867009905 | No Applicator Super Plus |
| 08016867008990 | Applicator Super Plus |
| 08016867008976 | Applicator Regular |
| 08016867008969 | Applicator Super |
| 38016867007390 | Organyc Cotton Tampon with bio-based Applicator. |
| 38016867007383 | Organyc Cotton Tampon with bio-based Applicator. |
| 38016867007376 | Organyc Cotton Tampon with bio-based Applicator. |