Hydrophilic Nitinol Guidewire

FDA UDI

Class I (US FDA UDI)

by Promepla

Identity

Trade Name: Hydrophilic Nitinol Guidewire FDA UDI
Generic Name: Ureteral catheter FDA UDI
Device Name: Diam. 0,035 Inch Length 150cm - 3cm Straight Flexible Tip FDA UDI
Model / Reference: 09-0141 FDA UDI
Description: Diam. 0,035 Inch Length 150cm - 3cm Straight Flexible Tip FDA UDI

Identifiers

Catalog Number: ROWP3502ST228 FDA UDI
Primary DI / UDI-DI: 03700512966463 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Ureteral catheter

Hydrophilic Nitinol Guidewire by Promepla — 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
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 I	Pending data

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Manufacturer

Manufacturer: Promepla

Sources (1)

FDA UDI 8c9dcc65-300b-4640-8540-f06e2ccfd4f7 34 fields · synced May 30, 2026