Catalog Number

193214

Brand Name

Control Syringe

Version/Model Number

193214

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

K911732,K911732

Product Code

IZI

Product Code Name

System, X-Ray, Angiographic

Public Device Record Key

d022fbb1-e820-41d7-af52-a05dfd868c92

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

20886333207248

Quantity per Package

25

Contains DI Package

00886333207244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box