Rael
Organic cotton cardboard applicator tampons, regular absorbency. Distributed in bulk.
10manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Fujian (2), Shandong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Niceday Sanitary Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Fujian Time AND Tianhe Industrial Co., Ltd. | Nanan | Fujian | Contract manufacturer | 9 |
| Guangdong Bingbing Health Care Products Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 7 |
| Fujian Tonggang Industries Ltd. | Quanzhou | Fujian | Manufacturer | 6 |
| Shandong Intco Hygiene Products Co., Ltd. | Zibo | Shandong | Contract manufacturer | 2 |
| Eisungrain (Shandong) Eco Technology Co., Ltd. | Zibo | Shandong | Exporter | 2 |
| Unibeauty (Hubei) Technology Co., Ltd. | Xiantao | Hubei | Manufacturer | 1 |
| Suzhou Borage Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
| Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | Huzhou | Zhejiang | Specification developer | 1 |
| Hangzhou Pengtu Chemical Fiber Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Rael, Inc., United States |
|---|---|
| FDA product code | HEB |
| Device type | Tampon, Menstrual, Unscented |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5470 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K191431 |
| Record published | 2023-03-24 |
| Record revised | 2023-03-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 24, pack of 12 |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RAEL-CTR18-V30-01 | In distribution | ||
| RAEL-CTS18-V30-01 | In distribution | ||
| RAEL-TPA-RG-V20-01 | In distribution | ||
| RAEL-TPA-SP-V20-01 | In distribution | ||
| RAEL-TS-V30-01 | In distribution | ||
| RAEL-TR-V30-01 | In distribution | ||
| Non Applicator Regular | 18 | Withdrawn | |
| Non-Applicator Super | 18 | Withdrawn | |
| Cardboard Applicator Super | 14 | Withdrawn | |
| Cardboard Applicator Regular – Bulk | 1,920 | Withdrawn | |
| Cardboard Applicator Super – Bulk | 1,540 | Withdrawn | |
| Cardboard Applicator Regular | 16 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tampax | Procter & Gamble Manufacturing Company, THE | 509 |
| U By Kotex | Kimberly-Clark Global Sales, Inc. | 185 |
| Playtex | Edgewell Personal Care Brands, LLC | 71 |
| Cora | Cora | 66 |
| CVS Health Tampons | Woonsocket Prescription Center, Incorporated | 61 |
| This is L | Procter & Gamble Manufacturing Company, THE | 46 |
| Walgreens | Walgreen Co. | 38 |
| Daye | Tampon Innovations Ltd OOD | 34 |
| H-E-B Tampons | H. E. Butt Grocery Company | 32 |
| Rite Aid Tampons | AL-BAD Massuot Yitzhak Ltd | 28 |
| DG Health Tampons | Dolgencorp, LLC | 23 |
| Kroger Tampons | Kroger Co., THE | 22 |
Showing 12 of 161. All products under Tampon, Menstrual, Unscented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182814 | 2019-07-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.