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Hayden Medical

FDA UDI

Class II (US FDA UDI)

by Hayden Medical Inc

Identity

Trade Name
Hayden Medical FDA UDI
Generic Name
Bladder-supporting pessary FDA UDI
Device Name
Incontinence Ring Pessary #5 with Support FDA UDI
Model / Reference
PRK3.00S FDA UDI
Description
Incontinence Ring Pessary #5 with Support FDA UDI

Identifiers

Catalog Number
PRK3.00S FDA UDI
Primary DI / UDI-DI
00840319717523 FDA UDI
510(k) Number
K092981 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bladder-supporting pessary

Hayden Medical by Hayden Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bladder-supporting pessary.

Cleared under the same submission

K092981 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hayden Medical Inc

Sources (1)

  • FDA UDI ded6d7ad-7760-4abe-988a-b9284043fb89 36 fields · synced Jun 8, 2026