Catalog Number

B109-DCT-SP

Brand Name

Steriatrics

Version/Model Number

100121-B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

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

K151960,K151960

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

31661e5b-916a-48a3-8efa-5380e99a921b

Public Version Date

July 30, 2020

Public Version Number

1

DI Record Publish Date

July 22, 2020

Package DI Number

26938327904146

Quantity per Package

20

Contains DI Package

06938327904142

Package Discontinue Date

July 22, 2020

Package Status

Not in Commercial Distribution

Package Type

carton