7 Fr. Ureteral catheter

FDA UDI

Class II (US FDA UDI)

by Urogen Pharma, Ltd.

Identity

Trade Name: 7 Fr. Ureteral catheter FDA UDI
Generic Name: Ureteral catheter FDA UDI
Model / Reference: Ureteral catheter FDA UDI

Identifiers

Primary DI / UDI-DI: 10854913006058 FDA UDI
510(k) Number: K180354 FDA UDI
FDA Product Code: KOD FDA UDI
GMDN Term: Ureteral catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5130 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: Catheter Length — 70 Centimeter FDA UDI
Catheter Gauge — 7 French FDA UDI

Category: Ureteral catheter

7 Fr. Ureteral catheter by Urogen Pharma, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ureteral catheter.

Bard® Polyurethane Ureteral Catheters, Open Tip — C. R. Bard, Inc. · Class II
Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
Bard® Woven Ureteral Catheter — C. R. Bard, Inc. · Class II
Novo Surgical — NOVO SURGICAL, INC. · Class I
Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
Coloplast — Coloplast A/S · Class II
UroForce® Balloon Dilation Catheter — C. R. Bard, Inc. · Class II
Metal Catheter — RZ-Medizintechnik GmbH · Class I

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: Urogen Pharma, Ltd.

Sources (1)

FDA UDI 209544db-48c4-4444-8561-41ca3180da20 34 fields · synced May 30, 2026