Catalog Number

IN9802

Brand Name

DiamondTOUCH™

Version/Model Number

00884450413463

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

f0299f0e-1654-4ad1-a3f2-094fd1881a94

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

October 14, 2019

Package DI Number

20884450413467

Quantity per Package

2

Contains DI Package

10884450413460

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-