Identity
- Trade Name
- EvaCare Pessary FDA UDI
- Generic Name
- Bladder-supporting pessary FDA UDI
- Device Name
- Pessary, Vaginal FDA UDI
- Model / Reference
- Ring w/ Support FDA UDI
- Description
- Pessary, Vaginal FDA UDI
Identifiers
- Catalog Number
- RS FDA UDI
- Primary DI / UDI-DI
- 08519520070049 FDA UDI
- 510(k) Number
- K993308 FDA UDI
- FDA Product Code
- HHW FDA UDI
- GMDN Term
- Bladder-supporting pessary FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.3575 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 4.00 Inch FDA UDIWidth — 3.75 Inch FDA UDIWidth — 3.50 Inch FDA UDIWidth — 3.25 Inch FDA UDIWidth — 3.00 Inch FDA UDIWidth — 2.75 Inch FDA UDIWidth — 2.50 Inch FDA UDIWidth — 2.25 Inch FDA UDIWidth — 2.00 Inch FDA UDIWidth — 1.75 Inch FDA UDIWidth — 1.50 Inch FDA UDI
EvaCare Pessary by Personal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K993308 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
- Personal Medical Corp.
Sources (1)
- FDA UDI 84901cda-2744-4962-8b8d-f879fd3250b6 38 fields · synced Jul 22, 2026