Catalog Number

BDRECANSYSTEMR

Brand Name

Recanalization System

Version/Model Number

BDRECANSYSTEMR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PDU

Product Code Name

Catheter for crossing total occlusions

Public Device Record Key

acc3f638-c9ef-4880-9d29-e3a835c4f4d4

Public Version Date

April 07, 2022

Public Version Number

1

DI Record Publish Date

March 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-