Catalog Number

-

Brand Name

NAMIC

Version/Model Number

85000435

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

IZI

Product Code Name

System, x-ray, angiographic

Public Device Record Key

921cd38e-dcf0-4996-b85f-184ca45d2fd7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2015

Package DI Number

H749850004351

Quantity per Package

10

Contains DI Package

H749850004350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX