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Milex

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
MILEX FDA UDI
Generic Name
Pelvic-organ-supporting pessary FDA UDI
Device Name
Shaatz Folding Pessary; 3 1/4" (83mm) FDA UDI
Model / Reference
MXPSH3-1/4 FDA UDI
Description
Shaatz Folding Pessary; 3 1/4" (83mm) FDA UDI

Identifiers

Primary DI / UDI-DI
00888937009156 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 is a high-quality, FDA-cleared pelvic-organ-supporting pessary designed to provide temporary or permanent support for women experiencing uterine prolapse. Made of durable materials and available in various shapes and sizes, this reusable device helps maintain the natural position of the organs within the pelvic cavity.

Similar devices

Also classified as Pelvic-organ-supporting pessary.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI d4688020-cc3b-4420-8a58-1f29c2802734 33 fields · synced Jul 10, 2026