Identity
- Trade Name
- Pixie Cup FDA UDI
- Generic Name
- Vaginal applicator, reusable FDA UDI
- Device Name
- Disc Applicator FDA UDI
- Model / Reference
- B0CGQ3YW9M FDA UDI
- Description
- Disc Applicator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850016867728 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
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- 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 |
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Manufacturer
- Manufacturer
- Pixie Cup, LLC
Sources (1)
- FDA UDI 5a93b296-2e75-4ae0-bb32-bb2766efedc0 33 fields · synced Jun 6, 2026