Identity
- Trade Name
- FEMTEX FDA UDI
- Generic Name
- Menstrual tampon, scented FDA UDI
- Device Name
- regular scented plastic applicator tampons FDA UDI
- Model / Reference
- FT11812SO FDA UDI
- Description
- regular scented plastic applicator tampons FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748364102007 FDA UDI
- 510(k) Number
- K050067 FDA UDI
- FDA Product Code
- HIL FDA UDI
- GMDN Term
- Menstrual tampon, scented FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5460 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
Yes
FDA UDI
Category: Menstrual tampon, scented
Femtex by First Quality Hygienic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Menstrual tampon, scented.
- SMART SENSE Tampons — KMART HOLDING CORPORATION · Class II
- Smart Sense Tampons — KMART HOLDING CORPORATION · Class II
- CVS Health Tampons — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
- H-E-B Tampons — H. E. BUTT GROCERY COMPANY · Class II
- Tampax — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC · Class II
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC · Class II
- Tampax — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
Cleared under the same submission
K050067 also covers:
- CareOne Tampons — Ahold U.S.A., Inc.
- DG Health Tampons — DOLGENCORP, LLC
- DG Health Tampons — DOLGENCORP, LLC
- FRED'S TAMPONS — FRED'S, INC.
- FRED'S TAMPONS — FRED'S, INC.
- FEMTEX — First Quality Hygienic, Inc.
- MEIJER TAMPONS — MEIJER, INC.
- MEIJER TAMPONS — MEIJER, INC.
- CVS HEALTH TAMPONS — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- CVS HEALTH TAMPONS — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- CVS HEALTH TAMPONS — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- First Quality Hygienic, Inc.
Sources (1)
- FDA UDI 4f3a376d-5752-4c7b-bdf4-e5e5341ea6b4 34 fields · synced Jun 1, 2026