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

GUDID

Device Identifier (DI) Information

Brand Name: B-Rail 3.5F Delivery Catheter
Version or Model: ABR-0346
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ABR-0346
Company Name: BEST VASCULAR, INC.

Primary DI Number: M097ABR03460
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789032039 *Terms of Use

Device Description: B-Rail 3.5F Delivery Catheter for the Novoste Beta-Cath System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
MOU	Intravascular Radiation Delivery System

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b3cc4d21-0edf-450b-bec9-61b2ef4dde70
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 10, 2015