FDA Registration
Active
🇺🇸 United States
PIXIE CUP LLC
Reg #: 3013865802
·
FEI: 3013865802
·
Expires 2026
Products
11
Proprietary Names
8
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- PIXIE CUP LLC
- Registration Number
- 3013865802
- FEI Number
- 3013865802
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 370 GAAR RD
- City
- Walnut Shade
- State
- MO
- ZIP
- 65771
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241365
Owner / Operator
- Firm Name
- PIXIE CUP LLC
- Operator Number
- 10061419
- Address
- 370 GAAR RD
- City
- Walnut Shade
- State
- MO
- Postal Code
- 65771
- Country
- US
- Correspondent
- Amber English
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2025-04-30 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2025-04-08 |
| Pad, Menstrual, Reusable | NUQ | Class 1 | Obstetrics/Gynecology | No | 2025-04-28 |
| Pelvimeter, External | HER | Class 1 | Obstetrics/Gynecology | No | 2025-08-12 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2021-08-19 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2026-01-08 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2024-06-13 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2023-11-01 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2026-05-21 |
| Cup, Menstrual | HHE | Class 2 | Obstetrics/Gynecology | No | 2019-10-16 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2023-10-30 |
Proprietary Names
Pixie Cup
Pixie
Pixie Reusable Pads
Pixie Womens Core Strength Set
Menstrual Cup Steamer
Pixie Pulse Replacement Gel Pads
Pixie Organic Cotton Tampons
Dot Cup
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198