DEVICE: B-Rail 3.5F Delivery Catheter (M097ABR03460)

Device Identifier (DI) Information

B-Rail 3.5F Delivery Catheter
ABR-0346
In Commercial Distribution
ABR-0346
BEST VASCULAR, INC.
M097ABR03460
HIBCC

1
789032039 *Terms of Use
B-Rail 3.5F Delivery Catheter for the Novoste Beta-Cath System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MOU Intravascular Radiation Delivery System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P000018 000
P000018 015
P000018 040
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b3cc4d21-0edf-450b-bec9-61b2ef4dde70
July 06, 2018
3
September 10, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
770-717-0904
xx@xx.xx
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