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Prostate Stepper Template

FDA UDI

Class II (US FDA UDI)

by Nucletron B.V.

Identity

Trade Name
Prostate Stepper Template FDA UDI
Generic Name
Prostate brachytherapy system applicator, remote-afterloading FDA UDI
Device Name
Fixation Bolt Tempate FDA UDI
Model / Reference
189168P01-02 FDA UDI
Description
Fixation Bolt Tempate FDA UDI

Identifiers

Primary DI / UDI-DI
08717213039889 FDA UDI
510(k) Number
K003270 FDA UDI
FDA Product Code
JAQ FDA UDI
GMDN Term
Prostate brachytherapy system applicator, remote-afterloading FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5700 FDA UDI
Commercial Distribution
Not 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

Prostate Stepper Template by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K003270 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 cbd30c00-b0d4-4cf7-b8e5-55e346dda5ff 36 fields · synced Jun 8, 2026