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Rael Organic Cotton Tampons: Regular Absorbancy
FDA UDIClass II (US FDA UDI)
by Rael Inc
Identity
- Trade Name
- Rael Organic Cotton Tampons: Regular Absorbancy FDA UDI
- Generic Name
- Menstrual tampon, unscented FDA UDI
- Device Name
- A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super. FDA UDI
- Model / Reference
- RAEL-TP-RG-01 FDA UDI
- Description
- A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856032008442 FDA UDI
- 510(k) Number
- K182814 FDA UDI
- FDA Product Code
- HEB FDA UDI
- GMDN Term
- Menstrual tampon, unscented FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Menstrual tampon, unscented
Rael Organic Cotton Tampons: Regular Absorbancy by Rael Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Rael Inc
Sources (1)
- FDA UDI 95fe24ff-2efa-4fc6-9a4b-82418314a26f 34 fields · synced May 30, 2026