Identity
- Trade Name
- Yoni.Fit Bladder Support FDA UDI
- Generic Name
- Urinary-incontinence vaginal insert, single-use FDA UDI
- Device Name
- Yoni.Fit Bladder Support Size 1 FDA UDI
- Model / Reference
- PT-1002 FDA UDI
- Description
- Yoni.Fit Bladder Support Size 1 FDA UDI
Identifiers
- Catalog Number
- Yoni Fit Size 1 Replacement FDA UDI
- Primary DI / UDI-DI
- 00850019563122 FDA UDI
- 510(k) Number
- K232525 FDA UDI
- FDA Product Code
- HHW FDA UDI
- GMDN Term
- Urinary-incontinence vaginal insert, single-use 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 34 Millimeter FDA UDI
Category: Urinary-incontinence vaginal insert, single-useUrinary-incontinence vaginal insert, reusable
Yoni.Fit Bladder Support by Watkins-Conti Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary-incontinence vaginal insert, reusable.
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- Revive — RINOVUM SUBSIDIARY 2, LLC · Class II
- Uresta® — Resilia, Inc. · Class II
- Uresta® — Resilia, Inc. · Class II
- Uresta® — Resilia, Inc. · Class II
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc. · Class II
Cleared under the same submission
K232525 also covers:
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc.
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
- Watkins-Conti Products, Inc.
Sources (1)
- FDA UDI 6d74d635-7d2b-4a7d-b50c-c8ba3c9bd5e7 38 fields · synced May 30, 2026