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ProGuide Needles

FDA UDI

Class II (US FDA UDI)

by Nucletron B.V.

Identity

Trade Name
ProGuide Needles FDA UDI
Generic Name
General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Device Name
ProGuide Obturator 5Fx240 mm FDA UDI
Model / Reference
189655-01 FDA UDI
Description
ProGuide Obturator 5Fx240 mm FDA UDI

Identifiers

Primary DI / UDI-DI
08717213052925 FDA UDI
510(k) Number
K060349 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

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 5.0 French FDA UDI
Length — 240.0 Millimeter FDA UDI

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

ProGuide Needles 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

K060349 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 59bac7b7-4161-4086-ab8a-a507594a2b0f 36 fields · synced Jun 8, 2026