Identity
- Trade Name
- Flexible Implant Tubes FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Radiopaque Button, yellow 1.9 mm FDA UDI
- Model / Reference
- 189293-00 FDA UDI
- Description
- Radiopaque Button, yellow 1.9 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213023567 FDA UDI
- 510(k) Number
- K032372 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
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Catheter Gauge — 6.0 French FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloading
Flexible Implant Tubes are a general-purpose brachytherapy system applicator designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area.
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Also classified as General-purpose brachytherapy system applicator, remote-afterloading.
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Cleared under the same submission
K032372 also covers:
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
- CT/MR OncoSmart Catheter System — Nucletron B.V.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nucletron B.V.
Sources (1)
- FDA UDI e8e8612d-da04-42f3-9830-f2374cb421f6 36 fields · synced Jul 22, 2026