Identity
- Trade Name
- Playtex FDA UDI
- Generic Name
- Menstrual tampon, unscented FDA UDI
- Device Name
- Playtex Sport Super 48 CT FDA UDI
- Model / Reference
- 11734 FDA UDI
- Description
- Playtex Sport Super 48 CT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00078300117346 FDA UDI
- 510(k) Number
- K060981 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
MR Safe FDA UDI
Category: Menstrual tampon, unscented
Playtex by Edgewell Personal Care Brands, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K060981 also covers:
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC
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
- Edgewell Personal Care Brands, Llc
Sources (1)
- FDA UDI 5c8ef2d8-d2c4-4658-8bc5-0d94ac2eec3e 34 fields · synced May 30, 2026