Identity
- Trade Name
- X-ray Catheters FDA UDI
- Generic Name
- Bronchial brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- X-Ray Catheter no.3, 140 cm for Flexitron FDA UDI
- Model / Reference
- 137801P01-02 FDA UDI
- Description
- X-Ray Catheter no.3, 140 cm for Flexitron FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213039728 FDA UDI
- 510(k) Number
- K132874 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Bronchial 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
MR Unsafe FDA UDI
Category: Bronchial brachytherapy system applicator, remote-afterloading
X-ray Catheters by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bronchial brachytherapy system applicator, remote-afterloading.
- Scaled pull rod, VariSource only — Varian Medical Systems Deutschland GmbH · Class II
- Scaled pull rod, GammaMed only — Varian Medical Systems Deutschland GmbH · Class II
- 4.7 Fr. plastic-tipped catheter, 150 cm — Varian Medical Systems Deutschland GmbH · Class II
- Centering Intraluminal Applicator Set — Varian Medical Systems Deutschland GmbH · Class II
- Guide tube for centering catheter — Varian Medical Systems Deutschland GmbH · Class II
- 4.7 Fr. plastic-tipped catheter, 100 cm — Varian Medical Systems Deutschland GmbH · Class II
- Centering Intraluminal Applicator Set — Varian Medical Systems Deutschland GmbH · Class II
- Lock screw for centering catheter, pack of 3 — Varian Medical Systems Deutschland GmbH · Class II
Cleared under the same submission
K132874 also covers:
- LumenCare Azure — Nucletron B.V.
- LumenCare Azure — Nucletron B.V.
- LumenCare Azure — Nucletron B.V.
- LumenCare Azure — Nucletron B.V.
- LumenCare Azure — Nucletron B.V.
- LumenCare Azure — Nucletron B.V.
- LumenCare Azure — Nucletron B.V.
- LumenCare Azure — Nucletron B.V.
- LumenCare Azure — Nucletron B.V.
- X-ray Catheters — 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 |
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Manufacturer
- Manufacturer
- Nucletron B.V.
Sources (1)
- FDA UDI 607b7042-429b-42d0-b186-508223481553 35 fields · synced Jun 8, 2026