Catalog Number

-

Brand Name

NAMIC

Version/Model Number

0449410

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"

Yes

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

K951802,K951802

Product Code

DXT

Product Code Name

INJECTOR AND SYRINGE, ANGIOGRAPHIC

Public Device Record Key

ab9298b2-5b89-4741-8fb1-2071bbf2522d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

H74904494102

Quantity per Package

10

Contains DI Package

H74904494100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX