Identity
- Trade Name
- Martinez Prostate Template FDA UDI
- Generic Name
- Prostate brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Template Holder for RTP Stepper FDA UDI
- Model / Reference
- 137282-04 FDA UDI
- Description
- Template Holder for RTP Stepper FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213055162 FDA UDI
- 510(k) Number
- K142439 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
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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Prostate brachytherapy system applicator, remote-afterloading
Martinez Prostate Template by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142439 also covers:
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
- Martinez Prostate Template — Nucletron B.V.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nucletron B.V.
Sources (1)
- FDA UDI 159a3f95-4aa0-4b5e-ab31-17bc3be34ae5 35 fields · synced Jun 1, 2026