← Back to catalogue

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
Stepper Holder Assembly for Tayman FDA UDI
Model / Reference
189083-02 FDA UDI
Description
Stepper Holder Assembly for Tayman FDA UDI

Identifiers

Primary DI / UDI-DI
08717213017108 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
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

No

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 Unsafe FDA UDI

Category: Prostate brachytherapy system applicator, remote-afterloading

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

Similar devices

Also classified as Prostate brachytherapy system applicator, remote-afterloading.

Cleared under the same submission

K003270 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nucletron B.V.

Sources (1)

  • FDA UDI 39881996-bf3b-4691-b2ea-6c3a3a0f9329 36 fields · synced May 30, 2026