Catalog Number

SY-1245

Brand Name

DeRoyal

Version/Model Number

SY-1245

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXT

Product Code Name

Injector and syringe, angiographic

Public Device Record Key

eeda93b5-ddcf-49b0-981d-e762bc7ce9f2

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Package DI Number

50749756802906

Quantity per Package

100

Contains DI Package

00749756802901

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case