Identity
- Trade Name
- EvaCare Pessary FDA UDI
- Generic Name
- Bladder-supporting pessary FDA UDI
- Device Name
- Pessary, Vaginal. Cube pessary is designed for third degree prolapse, cystocele and rectocele. FDA UDI
- Model / Reference
- Cube Pessary with Drain FDA UDI
- Description
- Pessary, Vaginal. Cube pessary is designed for third degree prolapse, cystocele and rectocele. FDA UDI
Identifiers
- Catalog Number
- CUD FDA UDI
- Primary DI / UDI-DI
- 08519520070025 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
- 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 — 25 Millimeter FDA UDIWidth — 29 Millimeter FDA UDIWidth — 33 Millimeter FDA UDIWidth — 37 Millimeter FDA UDIWidth — 41 Millimeter FDA UDIWidth — 45 Millimeter FDA UDIWidth — 50 Millimeter FDA UDIWidth — 56 Millimeter FDA UDIWidth — 63 Millimeter FDA UDIWidth — 70 Millimeter FDA UDIWidth — 75 Millimeter FDA UDI
Category: Bladder-supporting pessary
EvaCare Pessary by Personal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bladder-supporting pessary.
- HNM Women Care — HNM STAINLESS, LLC. · Class II
- HNM Women Care — HNM STAINLESS, LLC. · Class II
- HNM Women Care — HNM STAINLESS, LLC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Milex — CooperSurgical, Inc. · Class II
- Hayden Medical — Hayden Medical Inc · Class II
- HNM Women Care — HNM STAINLESS, LLC. · Class II
- Hayden Medical — Hayden Medical Inc · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Personal Medical Corp.
Sources (1)
- FDA UDI 378b34bb-f4c5-45fd-bd5c-a9f4922ea414 38 fields · synced May 30, 2026