Catalog Number

193249

Brand Name

Control Syringe

Version/Model Number

193249

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

5346220a-28bf-46d3-9ea3-2a27f9ae3002

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

20886333207330

Quantity per Package

25

Contains DI Package

00886333207336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box