Identity
- Trade Name
- MILEX FDA UDI
- Generic Name
- Pelvic-organ-supporting pessary FDA UDI
- Device Name
- Gellhorn Flexible with short stem Pessary; 2 3/4" (70mm) FDA UDI
- Model / Reference
- MXPGSS2-3/4 FDA UDI
- Description
- Gellhorn Flexible with short stem Pessary; 2 3/4" (70mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937007510 FDA UDI
- FDA Product Code
- HHW FDA UDI
- GMDN Term
- Pelvic-organ-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
No
FDA UDI
Category: Pelvic-organ-supporting pessary
Milex by CooperSurgical, Inc. — 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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 1d25e087-b606-4f24-9861-3aa9a5d929cf 33 fields · synced Jun 9, 2026