Catalog Number

IN7852

Brand Name

Blue Diamond™

Version/Model Number

00884450413432

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

-

Product Code

DXT

Product Code Name

Injector and syringe, angiographic

Public Device Record Key

6ae7d4a4-4732-4afe-b2c4-8f7a764a184c

Public Version Date

August 27, 2021

Public Version Number

1

DI Record Publish Date

August 19, 2021

Package DI Number

20884450413436

Quantity per Package

4

Contains DI Package

10884450413439

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-