Catalog Number

-

Brand Name

Antmed

Version/Model Number

710200

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"

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

K131770,K131770,K131770

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

4f930198-53e0-43f0-9f16-984de33c931d

Public Version Date

October 31, 2018

Public Version Number

4

DI Record Publish Date

August 24, 2017

Package DI Number

06945764403473

Quantity per Package

4

Contains DI Package

06945764403466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-