FDA UDI
In Commercial Distribution
🇺🇸 United States
B-Rail 3.5F XL Delivery Catheter
DI: M097BRX03460
·
Model: BRX-0346
·
BEST VASCULAR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- B-Rail 3.5F XL Delivery Catheter
- Primary DI
- M097BRX03460
- Version / Model
- BRX-0346
- Catalog Number
- BRX-0346
- Company Name
- BEST VASCULAR, INC.
- Labeler DUNS
- 789032039
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-10
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- cb823b67-7731-4418-a533-dd0a9b385b95
Device Description
Beta-Rail 3.5F XL Delivery Catheter for use with the Novoste Beta-Cath System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MOU | Intravascular Radiation Delivery System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61707 | Coronary artery brachytherapy system applicator, manual-afterloading | A sterile flexible tube intended to deliver/remove radiation therapy sources into a coronary artery, typically into the lumen of an implanted stent, as part of a manual-afterloading brachytherapy system. It is introduced into the patient and subsequently connected to the brachytherapy system source transfer device; it includes radiopaque markers to monitor the position of the radiation source. Disposable devices associated with the procedure may be included (e.g., syringe, connectors). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M097BRX03460 | HIBCC |
Customer Contacts
- Phone
- 770-717-0904
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000018 | 000 |
| P000018 | 040 |