Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical FDA UDI
Generic Name: Ureteral catheter FDA UDI
Device Name: zenith guyon (van buren) catheter stylet, 6 fr., curved, 14-1/2" (37.0 cm) FDA UDI
Model / Reference: UR96286-41 FDA UDI
Description: zenith guyon (van buren) catheter stylet, 6 fr., curved, 14-1/2" (37.0 cm) FDA UDI

Identifiers

Catalog Number: UR96286-41 FDA UDI
Primary DI / UDI-DI: G586UR96286410 FDA UDI
FDA Product Code: EYA FDA UDI
GMDN Term: Ureteral catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ureteral catheter

Novo Surgical by Novo Surgical, Inc. — Class I — 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
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
Bard® X-Force® Balloon Dilation Catheter — C. R. Bard, Inc. · 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 I	Pending data

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

Manufacturer

Manufacturer: Novo Surgical, Inc.

Sources (1)

FDA UDI 719caa88-f927-40db-ba5e-930d80c9a63e 35 fields · synced May 29, 2026