Catalog Number

622321

Brand Name

NA

Version/Model Number

622321

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2021

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

d60e146d-1fbe-446c-b977-f47dea6a794e

Public Version Date

July 30, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-