Naturelle 25176488
GUDID 10729661269447
Individually wrapped 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| Primary Device ID | 10729661269447 |
| NIH Device Record Key | bbc23df7-7260-4ff2-bea6-6e84c3c40f99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Naturelle |
| Version Model Number | 25176488 |
| Catalog Number | 25176488 |
| 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 | true |
| Manufacturing Date | true |
| 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 | false |
Customer Support Contacts
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com | |
| Phone | 419-841-2891 |
| compliance@impact-products.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10729661269447 [Primary] |
| HIBCC | B3402517650 [Previous] |
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-09 |
| Device Publish Date | 2024-02-01 |
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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