Bard® X-Force® Balloon Dilation Catheter

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name: Bard® X-Force® Balloon Dilation Catheter FDA UDI
Generic Name: Ureteral catheter FDA UDI
Device Name: Bard® X-Force® Balloon Dilation Catheter FDA UDI
Model / Reference: 997606 FDA UDI
Description: Bard® X-Force® Balloon Dilation Catheter FDA UDI

Identifiers

Catalog Number: 997606 FDA UDI
Primary DI / UDI-DI: 00801741052101 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 6 Millimeter FDA UDI
Length — 6 Centimeter FDA UDI
Balloon Length — 6 Centimeter FDA UDI

Category: Ureteral catheter

The Bard X-Force Balloon Dilation Catheter is a flexible, radiopaque tube designed for ureter dilation, bypassing partial obstructions, and irrigation/drainage during surgery. It features a single or double-lumen design, graduated markings, and a variety of tip configurations. This single-use device is used in medical procedures to remove kidney stones, perform retrograde urography, and aid in the insertion of guidewires.

Similar devices

Also classified as Ureteral catheter.

Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
Novo Surgical — NOVO SURGICAL, INC. · Class I
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 694b9cd7-b859-41a4-9434-7f0ff5b506e5 37 fields · synced Sep 17, 2026