Catalog Number

-

Brand Name

Antmed

Version/Model Number

200102

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

K072696,K072696

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

b96a2866-13bc-4ca5-bc0f-db6e89426030

Public Version Date

October 31, 2018

Public Version Number

4

DI Record Publish Date

December 15, 2016

Package DI Number

06945764411478

Quantity per Package

50

Contains DI Package

06945764400526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-