Identity
- Trade Name
- B-Rail 3.5F XL Delivery Catheter FDA UDI
- Generic Name
- Coronary artery brachytherapy system applicator, manual-afterloading FDA UDI
- Device Name
- Beta-Rail 3.5F XL Delivery Catheter for use with the Novoste Beta-Cath System FDA UDI
- Model / Reference
- BRX-0346 FDA UDI
- Description
- Beta-Rail 3.5F XL Delivery Catheter for use with the Novoste Beta-Cath System FDA UDI
Identifiers
- Catalog Number
- BRX-0346 FDA UDI
- Primary DI / UDI-DI
- M097BRX03460 FDA UDI
- PMA Number
- P000018 FDA UDI
- FDA Product Code
- MOU FDA UDI
- GMDN Term
- Coronary artery brachytherapy system applicator, manual-afterloading FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coronary artery brachytherapy system applicator, manual-afterloading
B-Rail 3.5F XL Delivery Catheter by Best Vascular, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coronary artery brachytherapy system applicator, manual-afterloading.
- B-Rail 3.5F Delivery Catheter — BEST VASCULAR, INC. · Class III
Cleared under the same submission
P000018 also covers:
- Accessories Kit — BEST VASCULAR, INC.
- Alpha VI 30mm Transfer Device — BEST VASCULAR, INC.
- Alpha VI 40mm Transfer Device — BEST VASCULAR, INC.
- Alpha VI 60mm Transfer Device — BEST VASCULAR, INC.
- B-Rail 3.5F Delivery Catheter — BEST VASCULAR, INC.
- Medical Physicist Kit — BEST VASCULAR, INC.
- Novoste Response Kit — BEST VASCULAR, INC.
- Procedure Accessory Pack — BEST VASCULAR, INC.
- Procedure Accessory Pack, 3.5F Coronary System, 5-Pack — BEST VASCULAR, INC.
- Temporary Storage Container — BEST VASCULAR, INC.
- Twin Transport Case — BEST VASCULAR, INC.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Best Vascular, Inc.
Sources (1)
- FDA UDI cb823b67-7731-4418-a533-dd0a9b385b95 36 fields · synced May 31, 2026