Catalog Number

128-100101

Brand Name

Ecomed Angiographic

Version/Model Number

128-100101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

f9e362ef-6b1d-457d-8a96-96ac2ed59d05

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2017

Package DI Number

10855009006150

Quantity per Package

50

Contains DI Package

00855009006153

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case