Identity
- Trade Name
- UroForce® Balloon Dilation Catheter FDA UDI
- Generic Name
- Ureteral catheter FDA UDI
- Device Name
- UroForce® Balloon Dilation Catheter FDA UDI
- Model / Reference
- 888406 FDA UDI
- Description
- UroForce® Balloon Dilation Catheter FDA UDI
Identifiers
- Catalog Number
- 888406 FDA UDI
- Primary DI / UDI-DI
- 00801741053108 FDA UDI
- FDA Product Code
- EZN FDA UDI
- GMDN Term
- Ureteral catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Dimensions & Sizes
- Size
- Length — 6 Centimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
Category: Ureteral catheter
UroForce® Balloon Dilation Catheter by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral catheter.
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
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- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Coloplast — Coloplast A/S · Class II
- Metal Catheter — RZ-Medizintechnik GmbH · Class I
- Porges Coloplast — Coloplast A/S · Class II
- Flexi-Tip — COOK INCORPORATED · Class II
- Sof-Flex — COOK INCORPORATED · 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 |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 4734a303-5ce5-434b-bca4-665d48562bf8 36 fields · synced May 30, 2026