Identity
- Trade Name
- Pixie Cup FDA UDI
- Generic Name
- Vaginal applicator, reusable FDA UDI
- Device Name
- Cup Applicator FDA UDI
- Model / Reference
- B0BCZMPVF9 FDA UDI
- Description
- Cup Applicator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850016867377 FDA UDI
- FDA Product Code
- HGD FDA UDI
- GMDN Term
- Vaginal applicator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal applicator, reusable
Pixie Cup by Pixie Cup, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal applicator, reusable.
- Reia — Reia, LLC · Class I
- Reia — Reia, LLC · Class I
- Premarin (conjugated estrogens) vaginal cream — Wyeth Pharmaceuticals LLC · Class I
- Reia — Reia, LLC · Class I
- Ring applicator — SOPRO-COMEG GmbH · Class II
- Premarin (conjugated estrogens) vaginal cream — Wyeth Pharmaceuticals LLC · Class I
- Ring applicator — SOPRO-COMEG GmbH · Class II
- Applicator — SOPRO-COMEG GmbH · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pixie Cup, LLC
Sources (1)
- FDA UDI c4501dbb-37d3-46c7-baa7-45b0e39fa02a 33 fields · synced May 29, 2026