X-ray Catheters

FDA UDI

Class II (US FDA UDI)

by Nucletron B.V.

Identity

Trade Name: X-ray Catheters FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: X-Ray Catheter Set 50 cm (10-18) FDA UDI
Model / Reference: 089090-01 FDA UDI
Description: X-Ray Catheter Set 50 cm (10-18) FDA UDI

Identifiers

Primary DI / UDI-DI: 08717213010260 FDA UDI
510(k) Number: K070574 FDA UDI
FDA Product Code: JAQ FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 30.0 Centimeter FDA UDI

Category: Radiological image marker, implantable

X-ray Catheters by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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X-Mark Ultra — IZI MEDICAL PRODUCTS LLC · Class II

Cleared under the same submission

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: Nucletron B.V.

Sources (1)

FDA UDI 79133e1d-6f8e-4535-99b7-09086aba86c3 36 fields · synced May 30, 2026