Catalog Number

IN7952/B

Brand Name

Blue Diamond™

Version/Model Number

00884450364000

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

bb995cfa-22e8-4a69-985a-8f84e4295259

Public Version Date

November 13, 2020

Public Version Number

1

DI Record Publish Date

November 05, 2020

Package DI Number

10884450364007

Quantity per Package

5

Contains DI Package

00884450364000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-