Identity
- Trade Name
- The Keeper FDA UDI
- Generic Name
- Menstrual cup/disc, non-latex, reusable FDA UDI
- Device Name
- The Keeper Menstrual Cup Size B FDA UDI
- Model / Reference
- KB FDA UDI
- Description
- The Keeper Menstrual Cup Size B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00787010222225 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
Yes
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: Menstrual cup/disc, non-latex, reusable
The Keeper by Gladrags Sustainable Women's Health, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Gladrags Sustainable Women's Health, Llc
Sources (1)
- FDA UDI 06353f56-fe8d-4860-ba6a-20409aac0e64 33 fields · synced Jun 1, 2026