Catalog Number

ER7232A

Brand Name

ER-REBOA Catheter

Version/Model Number

ER7232A

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

Yes

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

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

90c11054-f7e4-46d2-ad80-0ffd66f61aaf

Public Version Date

March 21, 2019

Public Version Number

2

DI Record Publish Date

July 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-