Identity
- Trade Name
- Milex FDA UDI
- Generic Name
- Bladder-supporting pessary FDA UDI
- Device Name
- Kit: Incontinence Ring Flexible Pessary #11; 4 1/2" (114mm) FDA UDI
- Model / Reference
- MXKPCON11 FDA UDI
- Description
- Kit: Incontinence Ring Flexible Pessary #11; 4 1/2" (114mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937004757 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
Yes
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Bladder-supporting pessary
Milex by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bladder-supporting pessary.
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- Medline — MEDLINE INDUSTRIES, 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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI dcacac1b-c173-4f35-b1b1-8a61cd79f65a 33 fields · synced Jun 9, 2026