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CT/MR OncoSmart Catheter System

FDA UDI

Class II (US FDA UDI)

by Nucletron B.V.

Identity

Trade Name
CT/MR OncoSmart Catheter System FDA UDI
Generic Name
General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Device Name
CT/MR OncoSmart Catheter Set (18 Ch), 240mm FDA UDI
Model / Reference
189418-01 FDA UDI
Description
CT/MR OncoSmart Catheter Set (18 Ch), 240mm FDA UDI

Identifiers

Primary DI / UDI-DI
08717213019614 FDA UDI
510(k) Number
K032372 FDA UDI
FDA Product Code
JAQ FDA UDI
GMDN Term
General-purpose brachytherapy system applicator, remote-afterloading 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 240.0 Millimeter FDA UDI

Category: General-purpose brachytherapy system applicator, remote-afterloading

CT/MR OncoSmart Catheter System by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose brachytherapy system applicator, remote-afterloading.

Cleared under the same submission

K032372 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nucletron B.V.

Sources (1)

  • FDA UDI c4fa47fa-694f-4e83-9314-f4672480dc65 36 fields · synced Jun 6, 2026