Identity
- Trade Name
- The DivaCup FDA UDI
- Generic Name
- Menstrual cup/disc, non-latex, reusable FDA UDI
- Device Name
- Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user. FDA UDI
- Model / Reference
- Model 0 FDA UDI
- Description
- Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user. FDA UDI
Identifiers
- Catalog Number
- FGCU000101 FDA UDI
- Primary DI / UDI-DI
- 00857538000237 FDA UDI
- 510(k) Number
- K021356 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
Yes
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
No
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
The DivaCup by Diva International Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K021356 also covers:
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 |
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Manufacturer
- Manufacturer
- Diva International Inc
Sources (1)
- FDA UDI 938dbe7f-771a-45b5-ad8d-15b43a7490be 36 fields · synced May 30, 2026