Identity
- Trade Name
- U by Kotex FDA UDI
- Generic Name
- Menstrual tampon, unscented FDA UDI
- Device Name
- U BY KOTEX SUPER PREMIUM MIXED TAMPON/PAD 3.833 CS FLOORSTAND DISPLAY 20 PKGS FDA UDI
- Model / Reference
- Tampon FDA UDI
- Description
- U BY KOTEX SUPER PREMIUM MIXED TAMPON/PAD 3.833 CS FLOORSTAND DISPLAY 20 PKGS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00036000464511 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
- Not 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
Yes
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Weight — 9 Gram FDA UDIWeight — 12 Gram FDA UDI
U by Kotex by Kimberly-Clark Global Sales, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Kimberly-Clark Global Sales, Inc.
Sources (1)
- FDA UDI e28ba6bd-1eb7-47ce-acbf-4f334dfcf515 36 fields · synced Jun 8, 2026