Identity
- Trade Name
- X-ray Catheters FDA UDI
- Generic Name
- Bronchial brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- X-Ray Catheter 150 cm (3) FDA UDI
- Model / Reference
- 089513P01-00 FDA UDI
- Description
- X-Ray Catheter 150 cm (3) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213041714 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 150.0 Centimeter 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
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 f449733e-30d1-4a43-b66d-3349c8f8a780 35 fields · synced Jun 8, 2026