FDA Registration
Active
🇺🇸 United States
Playtex Sport (Unscented) Tampons with OdorShield¿
Reg #: 2515444
·
FEI: 2515444
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- PLAYTEX MANUFACTURING INC.
- Registration Number
- 2515444
- FEI Number
- 2515444
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 804 Walker Rd
- City
- DOVER
- State
- DE
- ZIP
- 19904
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111684
Owner / Operator
- Firm Name
- EDGEWELL PERSONAL CARE BRANDS, LLC
- Operator Number
- 2515444
- Address
- 75 Commerce Drive
- City
- Allendale
- State
- NJ
- Postal Code
- 07401
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tampon, Menstrual, Scented, Deodorized | HIL | Class 2 | Obstetrics/Gynecology | No | 2012-07-11 |
Proprietary Names
Playtex Sport (Unscented) Tampons with OdorShield¿
Playtex Sport (Scented) Tampons with OdorShield¿
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device