Identity
- Trade Name
- UltuCup Box Model 1 EN/FR/ES FDA UDI
- Generic Name
- Menstrual cup/disc, non-latex, reusable FDA UDI
- Model / Reference
- Model 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628347063870 FDA UDI
- FDA Product Code
- HHE FDA UDI
- GMDN Term
- Menstrual cup/disc, non-latex, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5400 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Menstrual cup/disc, non-latex, reusable
UltuCup Box (1 EN +2 more) - 1 EN by Pamco Distributing Inc — Class II — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS
Similar devices
Also classified as Menstrual cup/disc, non-latex, reusable.
- MeLuna — MeLuna USA · Class II
- MeLuna — MeLuna USA · Class II
- COTTON HIGH TECH SL — COTTON HIGH TECH SL · Class II
- Angelcup - Lilac — Grupo IX Kaan, S.A. de C.V. · Class II
- Intimina Lily Cup Size B - EN — Leloi AB · Class II
- Oi — ORGANIC INITIATIVE CORPORATION · Class II
- MeLuna — MeLuna USA · Class II
- LEONA — LOON LAB INC. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pamco Distributing Inc
Sources (1)
- FDA UDI 1e08ecbc-f67b-4bb9-816e-b69242dab302 32 fields · synced Jun 8, 2026