Catalog Number

XD 8002

Brand Name

N/A

Version/Model Number

XD 8002

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

-

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

K171392,K192872,K210541,K171392,K192872,K210541,K171392,K192872,K210541

Product Code

IZQ

Product Code Name

Injector, contrast medium, automatic

Public Device Record Key

aaedaa71-dee2-4c59-bf35-4568b655250c

Public Version Date

June 08, 2022

Public Version Number

2

DI Record Publish Date

March 12, 2019

Package DI Number

04052536184521

Quantity per Package

10

Contains DI Package

04052536184514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-