Catalog Number

CCX010/C

Brand Name

Inject10n ™

Version/Model Number

00884450606704

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163084,K163084,K163084

Product Code

DXT

Product Code Name

Injector and syringe, angiographic

Public Device Record Key

d77452e6-bddb-4bf4-9b57-60dd60d3a8d1

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 30, 2022

Package DI Number

10884450606701

Quantity per Package

25

Contains DI Package

00884450606704

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-