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Titanium Needles

FDA UDI

Class II (US FDA UDI)

by Nucletron B.V.

Identity

Trade Name
Titanium Needles FDA UDI
Generic Name
General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Device Name
Titanium Needle Stopper Set FDA UDI
Model / Reference
110345P01-00 FDA UDI
Description
Titanium Needle Stopper Set FDA UDI

Identifiers

Primary DI / UDI-DI
08717213039346 FDA UDI
510(k) Number
K080871 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

No

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

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

Titanium 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

K080871 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 e051d931-ccf6-4429-b624-09b779c68d00 36 fields · synced Jun 8, 2026