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: 998610 FDA UDI
Description: Bard® X-Force® Balloon Dilation Catheter FDA UDI

Identifiers

Catalog Number: 998610 FDA UDI
Primary DI / UDI-DI: 10801741052726 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

Yes

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: Length — 10 Centimeter FDA UDI
Outer Diameter — 6 Millimeter FDA UDI
Balloon Length — 10 Centimeter FDA UDI

Category: Ureteral catheter

Bard® X-Force® 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
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: C. R. Bard, Inc.

Sources (1)

FDA UDI d8f86a3a-8af0-49f9-b919-00636b010a06 37 fields · synced May 30, 2026