Catalog Number

CCXB010/C

Brand Name

Inject10n ™

Version/Model Number

00884450606728

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

63543fa3-9ce1-4c91-94cb-d5f2549c4175

Public Version Date

June 06, 2022

Public Version Number

1

DI Record Publish Date

May 27, 2022

Package DI Number

10884450606725

Quantity per Package

25

Contains DI Package

00884450606728

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-