Naturelle
GUDID B34025160273
Individually packaged tampon
IMPACT PRODUCTS, LLC
Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented 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]
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