Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Bladder-supporting pessary FDA UDI
- Device Name
- PESSARY,MRLND,WO SUPPRT,SZ 7, 3.50",89MM FDA UDI
- Model / Reference
- MDS6301307 FDA UDI
- Description
- PESSARY,MRLND,WO SUPPRT,SZ 7, 3.50",89MM FDA UDI
Identifiers
- Catalog Number
- MDS6301307 FDA UDI
- Primary DI / UDI-DI
- 10888277631472 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
Category: Bladder-supporting pessary
A non-sterile plastic device designed for the management of female urinary incontinence and/or to reduce bladder prolapse. This ring-shaped support prosthesis is intended to be placed and held in the vagina with two prongs projecting forwards on each side of the urethral opening.
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
- 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
- HNM Women Care — HNM STAINLESS, LLC. · 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 |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 3b683949-f099-4f49-8c5d-ee7321f7c421 35 fields · synced Jul 19, 2026