Identity
- Trade Name
- MILEX FDA UDI
- Generic Name
- Pelvic-organ-supporting pessary FDA UDI
- Device Name
- KIT: Ring with support with knob folding Pessary #9; 4" (102mm) FDA UDI
- Model / Reference
- MXKPRSK09 FDA UDI
- Description
- KIT: Ring with support with knob folding Pessary #9; 4" (102mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937009035 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
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
Category: Pelvic-organ-supporting pessary
Milex by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pelvic-organ-supporting pessary.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 018d8450-7ff3-4c4a-afb7-6bdbc87ced6c 33 fields · synced Jun 9, 2026