Catalog Number

-

Brand Name

Single-use Syringe Kit

Version/Model Number

016605

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

K191060,K191060

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

ac27382e-fe0f-40a7-8a78-c80ff4889064

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Package DI Number

30841716102616

Quantity per Package

10

Contains DI Package

10841716102612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box