NiCore Nitinol Guidewire

FDA UDI

Class I (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name: NiCore Nitinol Guidewire FDA UDI
Generic Name: Gastro-urological guidewire, single-use FDA UDI
Device Name: NiCore Nitinol Guidewire, Guidewire with Hydrophilic Coating, Angle Tip, 0.035"(0.888mm) x 150cm FDA UDI
Model / Reference: 150NFA35 FDA UDI
Description: NiCore Nitinol Guidewire, Guidewire with Hydrophilic Coating, Angle Tip, 0.035"(0.888mm) x 150cm FDA UDI

Identifiers

Catalog Number: 150NFA35 FDA UDI
Primary DI / UDI-DI: 00801741051463 FDA UDI
FDA Product Code: EZB FDA UDI
GMDN Term: Gastro-urological guidewire, single-use 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

Dimensions & Sizes

Size: Outer Diameter — .035 Inch FDA UDI
Length — 150 Centimeter FDA UDI

Category: Gastro-urological guidewire, single-use

NiCore Nitinol Guidewire by C. R. Bard, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastro-urological guidewire, single-use.

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Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Optimos™ Guidewire — Taewoong Medical · 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

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Manufacturer

Manufacturer: C. R. Bard, Inc.

Sources (1)

FDA UDI ac91dbe4-4054-4457-8997-d3517949129a 36 fields · synced May 30, 2026