Naturelle
GUDID B34025160273
Individually packaged tampon
IMPACT PRODUCTS, LLC
Menstrual tampon, unscented| Primary Device ID | B34025160273 |
| NIH Device Record Key | a5ecbb8b-a216-4374-bf32-cbf653fc6ebe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Naturelle |
| Version Model Number | 251765 |
| Company DUNS | 005052360 |
| Company Name | IMPACT PRODUCTS, LLC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B34025160273 [Package] Contains: B3402517650 Package: Convenience Pack [50 Units] In Commercial Distribution |
| HIBCC | B34025160275 [Package] Contains: B3402517650 Package: Sample Pack [2 Units] In Commercial Distribution |
| HIBCC | B34025176488 [Package] Contains: B3402517650 Package: Carton [500 Units] In Commercial Distribution |
| HIBCC | B3402517650 [Primary] |
| HIBCC | B340A25176598 [Package] Contains: B3402517650 Package: Carton [200 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031067
FDA Product Code
| HEB | Tampon, Menstrual, Unscented |
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 | 2018-07-06 |
| Device Publish Date | 2017-01-26 |
On-Brand Devices [Naturelle]
| B34025160273 | Individually packaged tampon |
| B34025030073 | Pantyliners |
| 10729661269454 | Individually wrapped tampons |
| 10729661269447 | Individually wrapped tampon |
| 10729661269348 | Individually wrapped tampon |
Trademark Results [Naturelle]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.