Catalog Number

-

Brand Name

Antmed

Version/Model Number

500101

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)

-

Over the Counter (OTC)

Yes

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

7be23a5d-c5da-427a-9459-88d9be0e7a98

Public Version Date

October 16, 2019

Public Version Number

1

DI Record Publish Date

October 08, 2019

Package DI Number

06945764401561

Quantity per Package

50

Contains DI Package

06945764411553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-