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Reia

FDA UDI

Class II (US FDA UDI)

by Reia, LLC

Identity

Trade Name
Reia FDA UDI
Generic Name
Pelvic-organ-supporting pessary FDA UDI
Device Name
Size 1 Patient Pessary FDA UDI
Model / Reference
PP01-1 FDA UDI
Description
Size 1 Patient Pessary FDA UDI

Identifiers

Primary DI / UDI-DI
00860012119301 FDA UDI
510(k) Number
K232677 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

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

Category: Pelvic-organ-supporting pessary

Reia by Reia, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pelvic-organ-supporting pessary.

Cleared under the same submission

K232677 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Reia, LLC

Sources (1)

  • FDA UDI 4211069c-edb2-44ea-9203-0f1c5e2cb08e 34 fields · synced Jun 1, 2026